Quality Assurance Manager

Quality Assurance (QA) Manager required to provide leadership for the French Quality Assurance (QA) and Quality Control (QC) team, based at our offices in Grenoble, France.

Corin is looking for an experienced QA professional to take the lead in developing and executing strategies to strengthen our quality leadership position, and to prepare the organisation to meet the challenges of continued growth. As an active member of the management team, the Quality Assurance Manager will manage an effective quality system to assure the quality of products sourced, controlled, released, and distributed. This includes continuous improvement and driving quality metrics throughout the total quality process.

Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. We offer a unique combination of clinically proven hip & knee solutions and world leading technologies. Our OMNIBotics & OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.

The key responsibilities of the Quality Assurance Manager include:

- Directs the development, communication and implementation of quality policies, procedures, systems enhancements, budget, capital expenditures and projects.
- Successfully manages initiatives to achieve Company and functional profit, growth, operational efficiency, quality, coordinating and maintaining matrix relationship with internal & external stakeholders.
- Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820 and other regulations. Create, maintain, and manage robust Quality Systems accordingly.
- Lead the quality assurance & quality control team to:

- Ensure product quality during the appropriate processes and adherence to company procedures and to the applicable regulations and i.e. cGMP, ISO, FDA, EU-MDD, EU-MDR, etc.
- Initiate, maintain and ensure continuous improvement effort for the quality systems.
- Manage the system of French supplier evaluation. Conduct quality and process audits internally and at supplier locations.
- Manage the Calibration process.
- Maintain current library of process documentation, complaints and analyze products and returns to establish quality trends and implement corrective actions.
- Lead all inspections/audits required from regulatory authorities, customers, and prospects.
- Provide necessary interactions with regulatory authorities, audits, customers, and prospects. Interact with regulatory agencies to answer questions, plan meetings, obtain information, and otherwise facilitate regulatory communications.
- Responsible for creating and presenting Annual Management Reviews which contribute to discussions regarding Company’s quality, compliance, improved appropriate processes and product life cycle management.
- Investigates, reviews, and recommends new processes, policies and/or technology that would improve or enhance the department’s capability to deliver service, quality, compliance and build sales.
- Clearly communicate QA Metrics, QA results, concerns/issues, project status, corrective actions/status to the management team and other stakeholders
- Be proactive to minimize or eliminate quality and regulatory issues to help prevent any impact of adverse regulatory activities on the corporate reputation, market, or bottom line.
- Manage cost efficiency, quality assurance initiatives, budget, capital planning, performance reports, and project management and key performance measurements.
- Participates in harmonisation of QA globally and supports other Company sites with expertise where required.
- Manage change control and document control as well as the development of the Electronic Quality Management System.
- Administration and Maintenance of QS database (eQMS) and ROBAR system.
- Administration of the eTMS system. Identify and provide the training needs of all personnel.
- Co-ordinate with the Vigilance team activities of Field Actions, including required product rework/reprocessing.

**The ideal Quality Assurance Manager will have**:

- Recognised engineering-based degree or equivalent in a relevant field or 5 years of experience in the field of activity.
- Detailed knowledge of Quality Management Systems - 21 CFR 820 QSR, EU-MDD and EU-MDR, ISO 13485
- Proven Project Management and problem-solving skills.
- Good knowledge of Office Tools (Word, Excel, Internet, PowerPoint...) & ERP (SAGE / eQMS).
- Lead Assessor of Quality Management Systems Qualification is desirable.
- Fluent in both French and English (written and Oral)

Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran