Senior Quality Engineer (Hybrid)
Work Flexibility: Hybrid or Onsite
Senior Quality Engineer (Hybrid)
Stryker is hiring a Senior Quality Engineer in Leesburg, Virginia.
As a Senior Quality Engineer, you will lead quality issues with suppliers & partner with internal customers.
Work Flexibility: Hybrid or Onsite.
This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3 days onsite
Who we want
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do
- As a Senior Quality Engineer in working partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing supplier quality issues, development of suppliers and ensuring that our external supply chain are capable of meeting expectations from a quality, service and cost perspective.
- Lead quality issues with suppliers & partner with internal customers; Lead effective supplier containment and corrections/corrective actions.
- Lead internal and supplier driven non-conformances (NCs) and manage the timely closure of NC's.
- Lead CAPA projects and manage to timely root cause investigation, implementation and closure.
- Apply statistical methods of analysis and process control to current operations in support of management review, CAPA, and other quality system processes.
- Partner with suppliers and internal stakeholders to develop and revise PPAP documents. Throughout knowledge and understanding of process FMEAs, control plans, manufacturing process flows, and validations required.
- Work closely with operations and the business functions to ensure quality performance of product and processes.
- Ownership for supplier quality performance and measurement including KPI's and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews.
- Act as point of contact for Internal/ External Customer groups on key compliance issues related to suppliers.
- Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc).
- Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes.
- Participate in the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
- Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
- Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.
- Deliver continuous improvement activities focusing on supplier quality.
- Support the creation and maintenance of inspection methods and sampling.
- Support the development and review of process and equipment validation/qualification and MSA of internal processes.
- Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.
- Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
- Participate in supplier audit reviews for assigned suppliers as required.
- Participate in cross functional projects both locally & globally as required.
- Partner with SQE functions and Strategic Sourcing on the development and approval quality assurance agreements with suppliers.
What you need
- Bachelor's Degree
- 3+ years' experience in quality, manufacturing or engineering
- Technical Degree in relevant field
- Knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
- Knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
- Experience reading drawing specifications with an understanding of GD&T
- Demonstrated working knowledge to positively influence supplier quality performance, including prior experience working within manufacturing environments.
- Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma)
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
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