Supervisor, Quality Compliance
Key information
- Publication date:24 January 2025
- Workload:100%
- Contract type:Temporary
- Place of work:Rue Girardet, 2400 Le Locle
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Responsabilities
• Management of the complaint technicians’ team: Organize necessary resources to support activities. Ensure that goals and objectives are set and followed for every team member in accordance with the company’s G&O’s.
• Ensure polyvalence of the team
• Review and close complaint investigations for Le Locle
• Implementation and management of complaints procedures, investigation, trending, and product surveillance
• Ensures that Quality indicators (ex. Complaint, trends, etc.) are established and communicated
• Manage Health Hazard Evaluation when necessary: prepare the documentation and coordinate with others teams members (Design Quality Assurance, Medical Safety, Product Development, Post market Surveillance) to complete the required documentation
• Perform complaint trend analysis according to Integra GSOP: complete an investigation when necessary
• Participate to Post Market Surveillance activities : provide data
• Participate to risk analysis activities according to procedures and within the defined timeline
• Participate and support internal audits and third party audits / inspections
• Ensure that adequate Quality support is provided to production and to open projects / initiatives
• Ensure that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
• Ensures that GMP rules are known, understood and respected on the site
• Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
Qualifications
• A minimum of a Bachelors Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline.
• Minimum of 5 years of professional work experience within a quality assurance or compliance audit environment is required.
• Experience in a Medical Device manufacturing environment is preferred.
• Fluent in French and English
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian regulations, etc.
• Strong management skills
• Strong communication, organizational, negotiation and interpersonal skills
• Strong analytical problem solving skills.
• The ability to collaborate with all levels of management across multiple sites and functions
• Ability to interface with internal and external customers
• Use of Agile, Oracle, EtQ, Minitab, Trackwise
• Use of Microsoft office tools
• Knowledge of statistical techniques
Responsabilities
• Management of the complaint technicians’ team: Organize necessary resources to support activities. Ensure that goals and objectives are set and followed for every team member in accordance with the company’s G&O’s.
• Ensure polyvalence of the team
• Review and close complaint investigations for Le Locle
• Implementation and management of complaints procedures, investigation, trending, and product surveillance
• Ensures that Quality indicators (ex. Complaint, trends, etc.) are established and communicated
• Manage Health Hazard Evaluation when necessary: prepare the documentation and coordinate with others teams members (Design Quality Assurance, Medical Safety, Product Development, Post market Surveillance) to complete the required documentation
• Perform complaint trend analysis according to Integra GSOP: complete an investigation when necessary
• Participate to Post Market Surveillance activities : provide data
• Participate to risk analysis activities according to procedures and within the defined timeline
• Participate and support internal audits and third party audits / inspections
• Ensure that adequate Quality support is provided to production and to open projects / initiatives
• Ensure that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
• Ensures that GMP rules are known, understood and respected on the site
• Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
Qualifications
• A minimum of a Bachelors Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline.
• Minimum of 5 years of professional work experience within a quality assurance or compliance audit environment is required.
• Experience in a Medical Device manufacturing environment is preferred.
• Fluent in French and English
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian regulations, etc.
• Strong management skills
• Strong communication, organizational, negotiation and interpersonal skills
• Strong analytical problem solving skills.
• The ability to collaborate with all levels of management across multiple sites and functions
• Ability to interface with internal and external customers
• Use of Agile, Oracle, EtQ, Minitab, Trackwise
• Use of Microsoft office tools
• Knowledge of statistical techniques
Responsabilities
• Management of the complaint technicians’ team: Organize necessary resources to support activities. Ensure that goals and objectives are set and followed for every team member in accordance with the company’s G&O’s.
• Ensure polyvalence of the team
• Review and close complaint investigations for Le Locle
• Implementation and management of complaints procedures, investigation, trending, and product surveillance
• Ensures that Quality indicators (ex. Complaint, trends, etc.) are established and communicated
• Manage Health Hazard Evaluation when necessary: prepare the documentation and coordinate with others teams members (Design Quality Assurance, Medical Safety, Product Development, Post market Surveillance) to complete the required documentation
• Perform complaint trend analysis according to Integra GSOP: complete an investigation when necessary
• Participate to Post Market Surveillance activities : provide data
• Participate to risk analysis activities according to procedures and within the defined timeline
• Participate and support internal audits and third party audits / inspections
• Ensure that adequate Quality support is provided to production and to open projects / initiatives
• Ensure that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
• Ensures that GMP rules are known, understood and respected on the site
• Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
Qualifications
• A minimum of a Bachelors Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline.
• Minimum of 5 years of professional work experience within a quality assurance or compliance audit environment is required.
• Experience in a Medical Device manufacturing environment is preferred.
• Fluent in French and English
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian regulations, etc.
• Strong management skills
• Strong communication, organizational, negotiation and interpersonal skills
• Strong analytical problem solving skills.
• The ability to collaborate with all levels of management across multiple sites and functions
• Ability to interface with internal and external customers
• Use of Agile, Oracle, EtQ, Minitab, Trackwise
• Use of Microsoft office tools
• Knowledge of statistical techniques
Responsabilities
• Management of the complaint technicians’ team: Organize necessary resources to support activities. Ensure that goals and objectives are set and followed for every team member in accordance with the company’s G&O’s.
• Ensure polyvalence of the team
• Review and close complaint investigations for Le Locle
• Implementation and management of complaints procedures, investigation, trending, and product surveillance
• Ensures that Quality indicators (ex. Complaint, trends, etc.) are established and communicated
• Manage Health Hazard Evaluation when necessary: prepare the documentation and coordinate with others teams members (Design Quality Assurance, Medical Safety, Product Development, Post market Surveillance) to complete the required documentation
• Perform complaint trend analysis according to Integra GSOP: complete an investigation when necessary
• Participate to Post Market Surveillance activities : provide data
• Participate to risk analysis activities according to procedures and within the defined timeline
• Participate and support internal audits and third party audits / inspections
• Ensure that adequate Quality support is provided to production and to open projects / initiatives
• Ensure that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
• Ensures that GMP rules are known, understood and respected on the site
• Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
Qualifications
• A minimum of a Bachelors Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline.
• Minimum of 5 years of professional work experience within a quality assurance or compliance audit environment is required.
• Experience in a Medical Device manufacturing environment is preferred.
• Fluent in French and English
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian regulations, etc.
• Strong management skills
• Strong communication, organizational, negotiation and interpersonal skills
• Strong analytical problem solving skills.
• The ability to collaborate with all levels of management across multiple sites and functions
• Ability to interface with internal and external customers
• Use of Agile, Oracle, EtQ, Minitab, Trackwise
• Use of Microsoft office tools
• Knowledge of statistical techniques
Responsabilities
• Management of the complaint technicians’ team: Organize necessary resources to support activities. Ensure that goals and objectives are set and followed for every team member in accordance with the company’s G&O’s.
• Ensure polyvalence of the team
• Review and close complaint investigations for Le Locle
• Implementation and management of complaints procedures, investigation, trending, and product surveillance
• Ensures that Quality indicators (ex. Complaint, trends, etc.) are established and communicated
• Manage Health Hazard Evaluation when necessary: prepare the documentation and coordinate with others teams members (Design Quality Assurance, Medical Safety, Product Development, Post market Surveillance) to complete the required documentation
• Perform complaint trend analysis according to Integra GSOP: complete an investigation when necessary
• Participate to Post Market Surveillance activities : provide data
• Participate to risk analysis activities according to procedures and within the defined timeline
• Participate and support internal audits and third party audits / inspections
• Ensure that adequate Quality support is provided to production and to open projects / initiatives
• Ensure that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
• Ensures that GMP rules are known, understood and respected on the site
• Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
Qualifications
• A minimum of a Bachelors Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline.
• Minimum of 5 years of professional work experience within a quality assurance or compliance audit environment is required.
• Experience in a Medical Device manufacturing environment is preferred.
• Fluent in French and English
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian regulations, etc.
• Strong management skills
• Strong communication, organizational, negotiation and interpersonal skills
• Strong analytical problem solving skills.
• The ability to collaborate with all levels of management across multiple sites and functions
• Ability to interface with internal and external customers
• Use of Agile, Oracle, EtQ, Minitab, Trackwise
• Use of Microsoft office tools
• Knowledge of statistical techniques
Responsabilities
• Management of the complaint technicians’ team: Organize necessary resources to support activities. Ensure that goals and objectives are set and followed for every team member in accordance with the company’s G&O’s.
• Ensure polyvalence of the team
• Review and close complaint investigations for Le Locle
• Implementation and management of complaints procedures, investigation, trending, and product surveillance
• Ensures that Quality indicators (ex. Complaint, trends, etc.) are established and communicated
• Manage Health Hazard Evaluation when necessary: prepare the documentation and coordinate with others teams members (Design Quality Assurance, Medical Safety, Product Development, Post market Surveillance) to complete the required documentation
• Perform complaint trend analysis according to Integra GSOP: complete an investigation when necessary
• Participate to Post Market Surveillance activities : provide data
• Participate to risk analysis activities according to procedures and within the defined timeline
• Participate and support internal audits and third party audits / inspections
• Ensure that adequate Quality support is provided to production and to open projects / initiatives
• Ensure that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
• Ensures that GMP rules are known, understood and respected on the site
• Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
Qualifications
• A minimum of a Bachelors Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline.
• Minimum of 5 years of professional work experience within a quality assurance or compliance audit environment is required.
• Experience in a Medical Device manufacturing environment is preferred.
• Fluent in French and English
• Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian regulations, etc.
• Strong management skills
• Strong communication, organizational, negotiation and interpersonal skills
• Strong analytical problem solving skills.
• The ability to collaborate with all levels of management across multiple sites and functions
• Ability to interface with internal and external customers
• Use of Agile, Oracle, EtQ, Minitab, Trackwise
• Use of Microsoft office tools
• Knowledge of statistical techniques
