HireLevel is looking for a Senior Supplier Quality Engineer in St. Louis, MO!
Our client, a medical device manufacturer, is looking for a Senior Supplier Quality Engineer in the St. Louis area. The ideal candidate for this role will have new product development experience.
Job Title: Senior Supplier Quality Engineer
Job Category: Full-time and Part-Time, Long-Term Contract
Shift: Monday - Friday; 8:00 am - 5:00 pm
Location: St. Louis, MO
Similar Positions: Quality Engineer, Supplier
Responsibilities of Senior Supplier Quality Engineer:
- Represent Supplier Quality in internal project meetings and manufacturing readiness reviews and leads supplier on multiple Quality deliverables during qualification phases.
- 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 supplier questionnaires of potential suppliers.
- 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 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.
- Develop and maintain local supplier management procedures to ensure that regulatory, local and corporate requirements are met. Review and provide input to new/revised corporate procedures that impact the site.
- Perform supplier audits for new suppliers to assure products/services meet the requirements of applicable ISO standards, regulations, product specifications and local and corporate requirements.
- Responsibilities may include up to 15% travel.
- Reviews receiving inspection results and verify first receipt is accepted.
Reviews and approves supplier-related Change Notices and documentation for new products and/or services.
- 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.
- Ensure supplier documentation is maintained including risk assessments, quality agreements, and quality system certifications.
- 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.
Requirements of Senior Supplier Quality Engineer:
- BS in Business, Biology, Chemistry, Engineering or Pharmacy is required, Engineers or Technical degree is highly preferred.
- Must have 5+ years of Quality experience in the Medical Device Manufacturing industry; 3+ years in supplier quality related processes.
- Must have New Product Development experience, preferably in the medical device manufacturing industry.
- Strong ability to manage suppliers, follow-up and complete projects. Demonstrated hands on supplier management experience at FDA and ISO Regulated environment required.
- Responsible for developing & implementing quality processes in a global business environment, including supplier manufacturing sites.
- 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 Belts, Black Belts, and Master Black Belts.
- Excellent verbal and written communication skills. Ability to prioritize multiple tasks and projects with limited direct supervision. Effective organization and negotiation skills.
- Ability to pass client's background and drug screening requirements.
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