What are the responsibilities and job description for the Senior Quality Assurance Engineer position at GForce Life Sciences?
Senior Quality Assurance Engineer
14-Month Contract
Hybrid in Mahwah, NJ
Summary
Our client, a leading medical device company, has engaged GForce Life Sciences to provide a Senior Quality Assurance Engineer. This role provides quality engineering support across quality assurance, control, and preventative activities within operations and other business functions, with a focus on EU-MDR initiatives for a portfolio of products.
Responsibilities
- Provide quality engineering support for EU-MDR initiatives across a product portfolio.
- Develop and implement methods and procedures for process control, process improvement, testing, and inspection to support product compliance and performance.
- Support First Article Inspection (FAI) strategy development, execution, and approvals.
- Support Production Part Approval Process (PPAP) activities.
- Support change control and perform change impact assessments.
- Support SOP and risk documentation updates and reviews.
- Support equipment and process validations.
- Advocate and lead initiatives/projects to enhance quality performance and support compliance to regulations and standards.
Mandatory Requirements
- Bachelor’s degree in an engineering field (e.g., Biomedical Engineering, Mechanical Engineering, or related field).
- 4 years of industry experience.
- Experience supporting EU-MDR programs/initiatives.
- Excellent English (oral and written).
Nice to Have
- Firm understanding of medical device concepts.
- Familiarity with ISO 13485 and EU Regulations; GDP/GMP concepts.
- Knowledge of risk-based and statistical concepts.