1+ months

Senior Supplier Quality Engineer

Kelly Services
O'Fallon, MO 63368
Kelly Services is currently looking to hire a **Senior Supplier Quality Engineer** to work for one of our top Medical Device clients on-site in **OFallon, MO** for a direct position. This is an excellent opportunity to work for a renown company in an exciting industry.

The **Senior Supplier Quality Engineer** is **r** esponsible for Supplier Quality Assurance of new and existing product designs and product line extensions at the surgical business unit including, but not limited to product sourcing decision support; advanced product quality planning; suppliers assessment and qualification; validation of supplier processes; qualification of components, finished products and/or services; and concern resolution processes. Additionally, it may function in the same capacity to support maintenance of business (MOB) projects and cost improvement (CIP) projects, etc.


+ Represents Supplier Quality in internal and external project meetings and manufacturing readiness reviews and leads supplier activities on multiple Quality deliverables during qualification, approval, implementation phases, and lifecycle oversight of suppliers.

+ Acts as the Supplier Quality liaison between Manufacturing, R&D Engineering, Purchasing, Operations Quality, and the supplier.

+ Supports purchasing and R&D with source identification, evaluation, and selection. Leads On-Site Assessments and evaluation of supplier questionnaires, risk assessment and feasibility reviews.

+ Assists R&D and the project team in the definition of critical product characteristics and provides feedback on design manufacturability assessments to ensure a successful design transfer with robust specifications to suppliers.

+ Coordinates supplier quality activities necessary to fulfill general and specific requirements for product qualification such as First Article Inspection, receiving inspection processes, supplier process controls, capability studies for critical product characteristics and implementation of PFMEAs and control plans, process validation, among others.

+ Develops and maintains local supplier management procedures to ensure that regulatory, local, and corporate (Global) requirements are met. Review and provide input to new/revised corporate procedures that impact the site.

+ Manages audit schedule. Performs supplier audits for new suppliers to assure products/services meet the requirements of applicable ISO standards, regulations, product specifications and local and corporate requirements. Perform surveillance audits of existing supply base as needed per established procedure.

+ Leads/participate in Material Review Board.

+ Responsibilities may include up to 25% travel

+ Reviews receiving inspection results and verify first receipt is accepted.

+ Reviews and processes supplier-related Change Notices and documentation.

+ Ensures resolution of supplier related quality problems, including internal failures, customer complaints and audit findings by managing nonconforming product disposition, supplier investigation of root cause, corrective action planning, implementation, and verification of effectiveness.

+ Establishes, reports, and sustains key supplier quality performance metrics and corresponding training, improvements, and reporting responsibilities.

+ Ensures supplier documentation is maintained including risk assessments, quality agreements, quality system certifications and supplier status management.

+ Supports costs of quality reduction goals and supplier risk mitigation activities.

+ Authoring, reviewing and implementation of policies and procedures, to drive supplier quality improvement processes for continuous improvement.


+ BS in Business; Biology, Chemistry, or related field of science; Engineering; or Pharmacy (or equivalent experience)

+ 2-3 years in supplier quality related processes. Must have proven and results-driven track record of successfully managing projects, people, and suppliers. Responsible for developing & implementing quality processes in a global business environment, including supplier manufacturing sites.

+ Demonstrated hands on supplier management experience at FDA and ISO Regulated environment.

+ Excellent verbal and written communication skills.

+ Ability to prioritize multiple tasks and projects with limited direct supervision.

+ Effective organization and negotiation skills.

+ Strong ability to manage suppliers, follow-up, and complete projects.

+ Proficient in MS Office Applications

+ ASQ CQA, ISO Lead Auditor, or prior auditor experience required.


+ 5+ years Quality experience in the Medical Device Manufacturing industry

+ Additional consideration for experience in other highly regulated industries (automotive, aerospace, etc.) and for the following certifications: ASQ CQE, CQA, CQM and Six Sigma Green Belt, Black Belt, and Master Black Belt.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2022-05-27 Expires: 2022-07-28

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Senior Supplier Quality Engineer

Kelly Services
O'Fallon, MO 63368

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