New · posted Nov 8
Stryker · Medical Devices
Quality Specialist
- Kalamazoo, MI
- On-site
- Full-time
- Associate & Specialist
The role
Responsible for supporting quality processes in the manufacturing plant. Provide assistance and support to various quality engineering processes, drive improvement. Adheres to quality standards and follows guidelines to ensure parts, products, and processes meet specifications and requirements.
Work Flexibility: Onsite
What you need
- Demonstrated ability to build strong relationships
- Ability to lead as individual contributor
- Excellent organization, planning, communication, project management and performance attainment in quality environment
Preferred:
- Previous quality experience preferred
- 2 year Technical Degree or equivalent experience
- Professional certification such as ASQ certification (CQI, CQT, etc)
What you need
What you'll do
- Assist with investigations of nonconforming material in the MRB area
- Assist with investigation and disposition of finished good quarantined material.
- Investigate and disposition quarantined components.
- Communicate and coordinate with supplier on quality issues.
- Provide administrative support and assistance in managing Supplier Initiated Change Requests (SICRs).
- Assist with investigations of Out of Tolerance (OOT) calibration equipment and gages.
- Support and drive updates and changes to documents including mark-ups, rewrites, and routing changes in OnePLM
- Perform containment, investigation, and disposition of nonconforming material or process issues for nonconformances in eCAPA.
- Pull and trend metrics to support the quality teams and drive continuous improvement.
- Using data and other inputs, identify, prioritize, and deliver on business and customer needs.
- Accountable to meeting and/or exceeding business objectives including but not limited to safety, quality, delivery, customer experience, people development and cost.
- Partner with other cross functional areas on projects or operations initiatives to align when appropriate.
- Identify and execute quality improvement projects through teamwork, problem solving, and operating with high level of customer service.
- Participate in and support internal and external quality system audits.
Pay
$62,338 – $112,091 a year
Employer provided$29.97 – $53.89 an hour · yearly at 2,080 hours (40 a week)
How this comparesUnited States of America Pay Ranges
- USN: $29.97 - $41.45 USD Hourly
- US5: $31.47 - $43.53 USD Hourly
- US10: $32.97 - $45.60 USD Hourly
- US15: $34.47 - $47.67 USD Hourly
- US20: $35.97 - $49.74 USD Hourly
- US30: $38.97 - $53.89 USD Hourly
Where you'll work
Kalamazoo, MIOn-siteOpen in Maps (opens in a new tab)
More jobs in Kalamazoo, MIEqual opportunity, accessibility and legal noticesStryker's statements, word for word
View the U.S. work location and transparency guide to find the pay range for your location.Travel Percentage: NoneStryker 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.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US73 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $62,338 | — | $112,091 |
| All US (middle half) | $58,000 | $78,000 | $88,500 |
This role: Stryker's own published range, converted to a year at 2,080 hours. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 345 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Stryker's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- Investigations and CAPA5
- Quality systems and risk4
- GMP and compliance1
- Documentation and SOPs1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in medical devices, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
Company hiring pulse
Stryker on Regulatory Jobs
- 69
- Open roles
- 69
- Distinct roles
- 17
- Locations
By discipline
- Quality54 76%
- Regulatory12 17%
- Clinical5 7%
By level
- Senior & Principal40 56%
- Associate & Specialist23 32%
- Manager8 11%
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Quality Specialist at Stryker
Open until filled. $62K–$112K a year, employer provided.