Quality Assurance Engineer II
2 days ago
At Getinge, we are seeking a highly skilled Quality Assurance Engineer II to join our team. As a Quality Assurance Engineer II, you will play a critical role in ensuring compliance with FDA, ISO, and other medical device regulations.
Key Responsibilities:- Partner with Production Engineers to ensure compliance with regulatory requirements.
- Review current procedures and work instructions to determine compliance.
- Support Quality management, including investigating and documenting corrective and preventive actions.
- Communicate and coordinate quality improvement efforts with QA, R&D, and engineering management.
- Facilitate and consult with corrective action teams to implement changes.
- Support the creation and maintenance of QCRI-related Standard Operations Procedures and Work Instructions.
- Review and approve product/process qualification/validation and other change control related documentation.
- Support the Quality Control Receiving Inspection department with day-to-day activities.
- Maintain department metrology equipment and coordinate monthly equipment submission to the Calibration Lab.
- Purchase requisitions and sample submission activities in support of Collagen in-process testing with 3rd party labs.
- Creation and approval of Certificate of Conformance packages for Collagen customer orders.
- Maintenance and oversight of the Dock to Stock program for approved material.
- Coordinates technical activities regarding validations, including protocol development and synchronization of interdepartmental activities.
- Supports Supplier management, including non-conforming material review and supporting incoming material inspection.
- Supports quality planning by ensuring assigned quality plans and necessary gap assessments are documented, effective, and completed on time.
- Bachelor's degree in Manufacturing/Industrial, Mechanical, or Biomedical Engineering.
- 2-4 years in manufacturing and/or process engineering required. Experience in the medical device or other FDA regulated industry is preferred.
- Previous working knowledge in some of the following areas is required: continuous improvement processes, Kanban, equipment design, re-tooling, re-engineering and automation of production processes, manufacturing process support, and process development.
- Health, Dental, and Vision insurance benefits.
- 401k plan with company match.
- Paid Time Off.
- Wellness initiative & Health Assistance Resources.
- Life Insurance.
- Short and Long Term Disability Benefits.
- Health and Dependent Care Flexible Spending Accounts.
- Commuter Benefits.
- Parental and Caregiver Leave.
- Tuition Reimbursement.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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