Quality Assurance Engineer in Portage, MI at Stryker Corporation

Date Posted: 9/22/2019

Job Snapshot

Job Description

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.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do

As a Quality Assurance Engineer, you will be responsible for complaint handling, reliability improvement, quality management, quality systems, continuous improvement, project management and regulatory compliance.

Responsibilities:

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, MedWatch, Additional Information Requests)
  • Lead Customer Contact – Phone calls, letters, visits

Reliability Improvement

  • 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)
  • Business Unit Highlights – Monthly data analysis and trending to support Quality Plan (ex: prep data)
  • Support SQE’s (as needed)
  • 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 & 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)
  • Participate in new product development process acting as a feedback loop from the field

Regulatory Compliance

  • 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!)

What you need

Basic Qualifications:

  • Bachelor’s Degree in Engineering

Preferred Qualifications:

  • GPA of 3.0 or higher, strongly preferred
  • Med device industry knowledge
  • Competent with Microsoft Office (Outlook, Excel, Word, etc.)
  • Possess excellent oral and written communication skills (regularly speaking with external customers, sales force, service team's, regulatory bodies, and third-party distributors)
  • Ability to solve problems in a high stress situation
  • Eagerness to assist internal and external customers
  • Manage projects in a timely manner
  • Ability to conduct and document technical investigation
  • Root cause analysis tools and experience
  • Technical writing and drafting experience
  • Experience with GD&T and Statistical Analysis Capability, highly desirable

Physical Requirements

  • May involve prolonged periods of stooping, kneeling, crouching, bending, sitting, standing, and/or crawling as appropriate
  • May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job expectations
  • Coordination of eye, hand, and/or foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination/memory, reading ability, and memory retention ability
  • Requires use of safety glasses in designated areas
  • Closed-toe shoes must be worn on the production floor; safety shoes are recommended

Work From Home: No

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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