Supplier Engineer III

Job title: Supplier Engineer III

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions.

Apex has an opportunity for a Supplier Engineer III. For applicants who are interested in this opportunity, send your updated resume to the email above

Here are the details:

Position: Supplier Engineer III

Location: Hybrid

Project Duration: 12 months

This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for BSC’s contract manufactured (CM) sourced finished medical device (SFMD) product. This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with BSC team members and CM SFMD suppliers to execute deliverables according to business needs.

Responsibilities Include:

• Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve CM SFMD supplier’s process and inspection validations to BSC’s statistical requirements.
• Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
• Collaborate with CM SFMD suppliers and BSC functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
• In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Top Must-Haves:

• Bachelor’s degree in engineering is required!
• 2-5 years of experience in a manufacturing environment.
• Ability to travel up to 15% of the time. (Domestic possible.)

--Problem solving abilities

--Mfg. experience

--Validation experience

--Change management experience

Preferred qualifications:

• Experience working with suppliers or in supply chain management.
• Experience working in the Medical Device Field.
• Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
• Excellent communication and project management skills.
• Strong bias for action and results oriented.
• Self-driven and self-motivated to learn and apply knowledge to produce results.
• Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.

Looking for:

Problem solving, being able to showcase examples

Mfg. experience

Validation experience

Change management experience

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth 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 ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

Everforth Apex uses a virtual recruiter as part of the application process. Click here for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy

Everforth Apex

Benefits

• Overview: Everforth 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. Everforth 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, Everforth 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. Everforth 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 re