Senior Supplier Quality Engineer (Medical Device)

Job#: 3019948

Job Description:

Seeking a Supplier Quality Engineer to join a Medical Device company.

Core Needs:

Support with end-to-end External Manufacturing and Supplier Quality activities, including but not limited to: process validations, manufacturing site transfers, NC/CAPA root cause investigations, Change Control, Supplier Quality Agreement updates, Approved Supplier List (ASL) updates, metric analysis and reporting, process improvements.

Hands on production line experience and medical device experience

Key Responsibilities:

Provide sound, risk-based QA direction and independent and timely decision-making on a wide range of quality and compliance issues. Includes working with suppliers and internal resources to perform root cause analysis/failure investigations, identifying and approving of supplier corrective actions, and monitoring supplier's implementation / effectiveness. Provides oversight and escalation for product related issues.

Ensure compliant execution of Quality Management Systems including but not limited to EM: selection, change control, qualification, approved supplier list, NC/CAPA, Quality agreements and performance monitoring.

Provide leadership across activities associated with supplier risk identification & management, including planning and execution of supplier risk & control plan assessments and the ownership and creation of Quality Agreements.

Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship

Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements under limited supervision

Adaptable and flexible for other duties that may be assigned as needed

Qualifications

Education:

A minimum of a Bachelor's or equivalent University degree is required; a concentration in Engineering or related scientific field is preferred.

Experience and Skills:

Required:

A minimum of four (4) years of relevant work experience.

Experience leading and owning investigations, NCs, CAPAs or deliverables.

Critical thinking skills, excellent written and verbal communication skills with attention to detail.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.