New · posted Nov 8
Envista · Medical Devices
Nobel Biocare Quality Engineer, Manufacturing
- Yorba Linda, CA
- On-site
- Full-time
- Senior & Principal
The role
The Quality Assurance Engineer is responsible to ensure that production processes remain in a state of control, validation and verification activities are robust, and processes consistently produce medical devices that meet specifications. This role supports and ensures compliant execution of New Product Introduction and manufacturing Life Cycle Management activities and drive continuous improvement activities.
What you need
General Quality Accountabilities
- Support internal, and external audits
- Lead supplier audits
- Bachelor's degree in Engineering, Life Sciences or related disciplines.
- 6+ years of quality engineering experience in the medical device industry or equivalent regulated industry in a manufacturing environment.
- Hands-on expertise in root cause analysis tools such as 5-Why, Fishbone, Lean or Six Sigma methodologies.
- Practical experience with risk management tools (PFMEA).
- In-depth understanding and knowledge on standards and regulation including but not limited to:
- ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes.
- ISO 14971 - Medical devices - Application of risk management to medical devices.
- IEC 60812 - Failure modes and effects analysis (FMEA and FMECA).
- 21 CFR 820 QMSR - Quality Management System Regulation (FDA).
- Fluency in English.
PREFERRED QUALIFICATIONSnice to have
- Master's Degree preferred.
- Exercises independent work style and judgment in complex quality and compliance topics.
- Applies risk‑based thinking.
- Effective verbal and written communication skills across functions.
- Strong analytical, statistical, and documentation capabilities.
- Objective problem-solving skills with the ability to make firm, risk-based quality decisions under pressure.
IND123
Skills named in this posting
What you'll do
- Support the translation of process risk into PFMEA controls, control plans, standard work and -for-purpose in-process inspection.
- Ensure validations and verifications are robust, and oversee revalidation cycles.
- Ensure manufacturing-related procedures are strictly applied.
- Partner with manufacturing engineering to optimize inspection and testing methods.
- Participate in NPI and Lifecycle projects to ensure compliant execution thereof.
- Document, evaluate and track production non-conformances, and lead or facilitate containment, root-cause analysis, NCR and CAPA actions
- Use process, inspection and nonconformance data to detect variation, confirm capability and drive continuous improvement
- Partner with Operations and Engineering to follow standard work, manage changes and maintain accurate, traceable records.
- Support critical and time-sensitive topics, such as recalls, production issues, internal and external audits, corrective and preventive action
- Support the creation, implementation, training and continuous improvement of Quality Assurance processes.
- Act as a consultant for project teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities.
Pay and benefits
$105,200 – $128,600 a year
Employer providedTarget Market Salary Range
Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan
$105,200 - $128,600
Annual performance bonus
Medical/dental/vision benefits
401K match
Where you'll work
Yorba Linda, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Yorba Linda, CA
Equal opportunity, accessibility and legal noticesEnvista's statements, word for word
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% below the US median for Quality Engineering roles at this level.
This roleEmployer provided
Senior & Principal roles in California32 roles publishing pay
Senior & Principal roles in the US99 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $105,200 | — | $128,600 |
| California (middle half) | $130,500 | $148,000 | $170,250 |
| All US (middle half) | $105,250 | $123,500 | $144,000 |
This role: Envista's own published range. Comparisons: the base pay employers published on open Quality Engineering roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Engineering
The general path across 213 open Quality Engineering roles on Regulatory Jobs, with the titles they carry most. Not Envista's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance10
- Quality systems and risk8
- Documentation and SOPs5
- Collaboration and leadership5
- Lab testing and methods3
- Investigations and CAPA3
- Validation and qualification2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Engineering work in medical devices, led by the three 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 14971(official source, opens in a new tab)Application of risk management to medical devicesNamed in the posting
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
Company hiring pulse
Envista on Regulatory Jobs
- 13
- Open roles
- 13
- Distinct roles
- 8
- Locations
By discipline
- Quality8 57%
- Regulatory4 29%
- Clinical2 14%
By level
- Manager5 36%
- Associate & Specialist5 36%
- Senior & Principal3 21%
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Nobel Biocare Quality Engineer, Manufacturing at Envista
Open until filled. $105K–$129K a year, employer provided.