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Senior Staff Supplier Quality Engineer in Portage, MI at Stryker Corporation

Date Posted: 3/15/2019

Job Snapshot

  • Employee Type:
  • Location:
    Portage, MI
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

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.

Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

What you will do

Responsibilities related to compliance:

  • Ensure components, sub-assemblies, and devices meet all print specifications and applicable regulations.
  • Work with suppliers to quarantine all suspect and non-conforming material.
  • Issue supplier corrective action requests, and drive suppliers to identify and address true root cause.
  • Participate on supplier audits, as required.
  • Train/educate suppliers on GMP, regulatory requirements, and Stryker expectations.

Responsibilities related to sustainment:

  • Ensure an un-interrupted supply of conforming components to Stryker Operations.
  • Root cause analysis of part related manufacturing defects and warranty concerns
  • Manage supplier-initiated changes; serve as the “change owner” in Stryker’s change management system.
  • Update prints and generate Engineering Change requests.
  • Update gage plans and attribute charts.
  • Serve as a subject matter expert, for your assigned commodity; share expertise within global Stryker organization.
  • Support manufacturing transfer projects.
  • Support strategic sourcing projects
  • Disposition material quarantined in MRB.

Responsibilities related to development:

  • Foster strong relationships with Stryker’s supplier-partners.
  • Analyze non-conformance data to prioritize projects and to solve systemic supplier issues.
  • Create and execute supplier development plans.
  • Drive continuous improvement actions with suppliers to reduce part related defects.
  • Evaluate and qualify of new suppliers, especially those with advanced technologies, to support product innovation.
  • Support strategic sourcing decisions by identifying supplier capabilities and providing input for supplier selection.
  • Make pro-active supplier site visits.
  • Train/educate suppliers on Quality topics:  Quality System, problem solving, validation, and lean.
  • Push “lessons learned” from the supply base back to R&D for incorporation into next generation designs.

What you need:

Basic Qualifications:

  • Bachelor’s Degree
  • Minimum 7 years’ experience in quality, engineering, compliance or working in a heavy regulated environment.  

Preferred Qualifications:

  • Experience in medical device industry preferred.
  • Experience working onsite developing suppliers preferred.
  • Experience conducting supplier audits and internal audits preferred.
  • Demonstrated collaboration, negotiation, and conflict resolution skills.
  • Expertise with quality systems; ISO13485 & ISO9001 experience preferred.
  • Expertise in production and process controls.
  • Expertise in problem solving and root cause analysis.
  • Strong knowledge of quality planning tools:  APQP, PPAP/FAI, FMEA, MSA, Control Plan, & Control Charts.
  • Strong knowledge of statistics and use of Minitab software:  SPC, MSA, DOE, and Process Capability.
  • Demonstrated process knowledge in assigned commodity (i.e. plastics, metals, electronics, PCBAs, etc.)
  • Strong knowledge of verification and validation, per FDA-QSR.

Work From Home: No

Travel Percentage: Up to 50%

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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