Sr. Quality Engineer
Responsible for complaint handling, reliability improvement, quality management, quality systems, continuous improvement, quality systems engineering, project management and regulatory compliance. Knows and applies the fundamental and some advanced concepts, practices and procedures of the quality specialization.
Complaint Handling and Reliability Improvement:
- Deliver Exceptional Customer Service to Complaint Originator
- Resolve Potential MDR Investigations
- Close Complaint Investigations
- Champion Root Cause Problem Solving
- Perform Risk Analysis and Reduction
- Author Quality / Regulatory Technical Reports (QRTR's)
- Lead Customer Contact - Phone calls, letters, visits
- Draft monthly bulletins to Field Service Reps on the status of quality and improvements made
- Trend service reports to identify top product issues and drive resolution
Quality Management / Quality Systems / Continuous Improvement:
- Support Operations - Ongoing support of critical quality issues as needed (ex: ship hold)
- Lead Quality Planning - Create and drive Quality Plan for Business Unit with COE Quality Leader
- Business Unit Highlights - Monthly data analysis and trending to support Quality Plan (ex: prep data)
- Statistical Support - Lead Sample size selection, SPC, DOE, etc.
- Support SQE's (as needed)
- Material Review Board (MRB)
- Fabrication - Tooling Certification, Gage Plans, Gage R&R, Validation Support
- Vendor Management - Identify vendor quality issues and drive improvements
- Cost Reduction Team Support - Support initiatives as needed
- Special Projects - As needed by Business Unit and Department
- Support ECO & CAPA processes to ensure thorough and robust outcomes and enforce quality compliance (ex: Gage plans, FA, etc)
- Lead Quality centric problem solving 8D's and CAPA's
Quality Systems Engineering and Project Management:
- Identify opportunities for enhancement of existing quality and regulatory systems/tools in support of our departmental and divisional visions.
- Provide quality support as a consultant to our organization to build understanding of quality concepts and drive our quality culture.
- Support AQE's (as needed):
- Provide engineering specification and product design support to R&D teams through robust design practices (GD&T, etc)
- Participate in drawing development
- Develop control plans and inspection procedures
- Support GR&R with Metrology Specialist & AQT
- Participate in new product development process acting as a feedback loop from the field
- Conduct Monthly Spider Web Audits and Quarterly Team Audits as required
- Participate in internal compliance audits - FDA, ISO, and Internal Audits
- Support external audits - Vendor and Sister Divisions
- Monitor compliance to Medical Quality Procedures and FDA Quality System Regulations (QSR's) and update as necessary
- Regulatory Training - Conduct and support training on QSR's, ISO, and RA Topics
- Monitor the ECO & CAPA processes meet all compliance requirements (ex: Write it Right!)
- Has some latitude for unreviewed action or decisions.
- Usually works with minimum supervision, conferring with superiors on unusual matters.
- Viewed as a team resource in an area of expertise.
- Bachelors Degree in Engineering or related field
- Minimum of 2-3 years experience in field of specialization
- Achieved an advanced (learning) level of industry knowledge
- Competent with Microsoft Office (Outlook, Excel, Word, etc.)
- Must possess excellent oral and written communication skills
- Ability to solve problems in a high stress situation and to make effective decisions
- Possess attention to detail
- Eagerness to assist internal and external customers
- Manage projects in a timely manner
- Ability to conduct and document technical investigation
- Experience with GD&T and Statistical Analysis Capability
Work From Home: No
Travel Percentage: Up to 25%
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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