Compliance Quality Engineer
Position: Compliance Quality Engineer
Department: Quality Assurance
Reports to: Quality Manager
The Compliance Quality Engineer is responsible for upgrading and maintaining the DNAG Quality Management System (QMS) to assure compliance with the current issues of ISO 13485, ISO 9001 and regulatory requirements.
RESPONSIBILITIES / DELIVERABLES:
- Perform gap analyses against quality standards, propose and implement improvements to assure continued compliance.
- Perform internal audits against standards, regulations and internal procedures.
- Ensure that the DNAG service offerings are adequately covered in the QMS.
- Support the configuration management processes between DNAG and its contract manufacturers.
- Support the risk management process.
- Support new product introduction, including risk management, design review, FMEAs, design transfer, quality planning, etc.
- Host external audits by registrars, regulators and customers.
- Support the CAPA and complaint processes.
- Other duties deemed appropriate for a Quality Engineer.
- Degree in a science or engineering discipline, or an equivalent combination of relevant job experience, training and knowledge.
- Recognized Quality Management System training or certifications such as Certified Quality Engineer, Certified Supplier Quality Engineer,
- ISO 9001 / 13485 auditor certification an asset.
- Minimum 5 years experience in an engineering role preferably in the medical device or similarly regulated industry.
- Experience building productive, collaborative relationships with key external suppliers
- Demonstrated resourcefulness and ability to work with a diverse set of tasks and responsibilities.
- Strong time management and organizational skills
- Excellent written and oral communication skills.
- Experience with internal audits.
- Familiarity with ISO 9001, ISO 13485:2003 and medical device GMP regulations.
- Proficiency in MS Office Applications.
- Willingness to travel to supplier or customer sites.
Send application letter and resume to firstname.lastname@example.org