Quality Assurance Specialist

Quality Assurance Specialist - Diegem, Belgium

General Summary Establish and maintain a robust compliance program to ensure compliance with local, national and international regulatory standards, company policies and procedures, and Johnson & Johnson corporate requirements. Coordinate and deploy sector policies and standards, as well as maintain specific onsite quality systems, as required. Partnering with European manufacturing plants and key business partners:

- Maintain quality systems, including but not limited to: document management, training program, external audits and internal auditing program.
- Monitor and ensure Due Date Adherence for these Quality Subsystems and report to management.
- Lead on-going efforts to improve GMED Quality System where applicable.
- Work effectively with the other GMED departments and corporate liaisons to ensure consistent/effective quality systems.
- Support site Quality system related improvement projects.
- Support CAPA and NC process
- Assures that non-conformance investigations and quality systems are in compliance with the good manufacturing practices as established in the code of local government regulations and company procedures.
- Utilize effective risk management tools to prevent unanticipated failure modes and ensure capability.
- Develop and implement appropriate Quality Procedures.
- Refers extraordinary situations to the quality assurance manager for final approval.
- Leads and supports the facility in identifying and eliminating compliance risks.
- Prepares quality agreements for suppliers, contractors and affiliates and schedules audits for compliance.
- Ensures that appropriate specifications and procedures are in place.
- Ensure effective change control.
- Ability to work under own initiative with minimum supervision.

Principal Duties and Responsibilities

- Participate in project teams relating to Quality.
- Implement and ensure ongoing maintenance of the Internal Audit plan.
- Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action.
- Ensure compliance with company policies and procedures.
- Provide guidance and recommendations involving the implementation of regulatory requirements (eg Quality System Regulation, EU MDD, ISO standards, etc.)
- Reports any non-conformance's to the quality assurance manager.
- Partner with MD manufacturing plants and key business partners.
- Partner with distribution centers and affiliates in the investigation/correction of process failures.
- Proactively communicate any changes in design or changes in process that could affect product.
- Ensure distribution centre and affiliate performance is monitored and addressed as needed.
- Provide leading metrics to Quality Assurance Manager

Non Technical Skills

- Appropriate Engineering, Life Science, Physical Science or Business Degree.
- PE Green Belt or Black Belt certified
- Related experience to demonstrate skills required.
- Demonstrated knowledge and application of QSR, MDD, ISO9001, 9002, 13485, 14971 and other international standards.
- Working knowledge of Good Distribution Practice.
- Practical experience of Lean Manufacturing and Lean tools.
- Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Project).
- Effective communication skills.
- Effective technical writing.
- Sense of urgency, intellectual curiosity, prudent risk-taking.

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.