Sr Quality Engineer

Quality Assurance Manager

The candidate works closely with Manufacturing Technicians and Engineers to provide quality oversight of production lines and guidance during production line down situations. The candidate will engage in a collaborative, diversified, and energetic team environment focused on delivering high-quality products to our patients and users. The ideal candidate will have experience with the management of non-conforming products, process validation, and product change control and have a strong foundation/working knowledge of FDA regulations and ISO standards for medical devices.

• Oversight of Non-conforming product dispositions and completions

• Oversight of Process Validation activities, including non-product equipment/software validations and Test Method Validations

• Support of CAPA actions and deliverables

• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product

• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment

• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

• Designs or specifies inspection and testing mechanisms and equipment, conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.