New · posted Nov 11
Stryker · Medical Devices
Senior Inspector, Quality
- Mahwah, NJ
- On-site
- Full-time
- Senior & Principal
The role
Work Flexibility: Onsite
Schedule: 1st Shift | Monday to Friday | 5:00am to 1:30pm | Optional OT
What you need
Who We Want
A technically strong, detail-oriented inspector with a solid foundation in dimensional measurement and GD&T, who can operate independently, support their team and help drive quality and scheduling across incoming inspection. Someone with strong communication skills who can coordinate across departments and bring structure to daily workload planning.
- 5+ years of product inspection experience, preferably within an ISO 13485, cGMP, medical device, or other highly regulated manufacturing environment
- Strong working knowledge of GD&T and ability to interpret complex engineering drawings
- Demonstrated experience with CMM, OGP, optical comparators and precision measurement tools
- Proficiency in Microsoft Excel for data analysis and reporting
- High School Diploma or equivalent required; vocational or technical training in manufacturing, quality or metrology preferred
Preferred:
- Formal GD&T training
31.90 USD Hourly
What you'll do
- Perform dimensional and visual inspection of incoming materials and components against engineering drawings, specifications and acceptance criteria
- Set up and operate CMM, optical comparator, OGP and other precision measurement equipment
- Interpret complex blueprints and apply GD&T requirements during inspection
- Perform and review First Article Inspections (FAI) and sampling activities
- Prioritise and coordinate inspection workload based on production schedules, material demand and business priorities
- Communicate inspection status and material priorities with Quality, Operations and Planning teams
- Analyse inspection data to identify trends, recurring defects and improvement opportunities
- Support incoming inspection KPIs and contribute to process and method improvements
- Identify, document and control nonconforming material in line with established procedures
- Support quality and supplier investigations with measurement data and technical input
- Maintain accurate inspection records in line with GDP, cGMP and quality system requirements
- Provide technical guidance, training and cross-training support to other inspectors
Where you'll work
Mahwah, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Mahwah, NJEqual opportunity, accessibility and legal noticesStryker's statements, word for word
Travel Percentage: 0%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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US8 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $53,625 | $59,000 | $63,625 |
Comparisons: the base pay employers published on open Quality Inspection roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Inspection
The general path across 102 open Quality Inspection 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.
- GMP and compliance10
- Collaboration and leadership5
- Quality systems and risk3
- Documentation and SOPs2
- Investigations and CAPA2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Inspection work in medical devices, led by the two this posting names, 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 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDA21 CFR Part 801(official source, opens in a new tab)FDA labeling requirements for medical devices
- ISOISO 15223-1(official source, opens in a new tab)Symbols for medical device labels and labeling
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
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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Senior Inspector, Quality at Stryker
Open until filled.