New · posted Nov 8
Philips · Medical Devices
Senior Quality Operations Engineer
- Bedford, MA
- On-site
- Full-time
- Senior & Principal
The role
The Senior Quality Operations Engineer is responsible for supporting a state of high-quality performance, compliance, and oversight/performance monitoring of Philips manufacturing processes, driving compliance and continuous improvement throughout the manufacturing process.
How we work together
We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an ON-SITE role.
What you need
You're the right fit if
- You have a minimum of 5+ years’ experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments, with a focus on quality operations, audit support, process validation/improvement, CAPA, non-conformance, PFMEA’s and Change/Risk Management (ISO 14971).
- You have proven experience leading cross-functional teams
- You have detailed experience/knowledge in CAPA processes non-conformances, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
- You’re experienced in utilizing Quality) insights/data analytics to lead continuous improvement.
- You’re able to build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.
- Previous experience in environmental control programs and sterilization validation.
- You have a minimum of a Bachelor’s Degree in Engineering. ASQ-CQE, ISO Lead Auditor certifications-desired
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
What you'll do
Your role
- Support operations performance monitoring, reporting, improvement and development, facilitate quality improvement programs in factories.
- Handles nonconformance events/investigations in the factory, leverages Process Failure Mode and Effects Analysis (PFMEA) to assess risk, guides material review board activities for non-conformance disposition management, leads analysis of defects for determining dispositions of non-conformances, drives management of Non-Conformances (NC) and facilitates implementation of effective Corrective and Preventive Actions (CAPA) actions
- Facilitates timely quality engineering and quality assurance tasks, ensures manufacturing quality systems are maintained, handles single or complex process validation and process improvement activities, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
- Possesses working knowledge Quality Engineering and Continuous Improvement techniques, follows processes and operational policies in selecting methods for obtaining solutions, and frequently interacts with supervisors and functional peer groups to gain cooperation of others
- Leads validation protocols, facilitates production builds to support validation activities, analyzes data for reports, process improvement initiatives, and validation activities.
- Utilizes advanced statistical analysis methods to interpret complex data trends, resolve a wide range of moderate complexity requests, and provide strategic insights for continuous enhancement of quality standards and process efficiency.
- Ability to interpret and/or create detailed, quality metrics and reports with stakeholders, highlighting significant achievements, emerging trends, and actionable insights to drive advanced improvement initiatives and ensure regulatory compliance.
- Delivers training programs on quality standards, advanced methodologies, and best practices, fostering alignment across functions and advancing excellence in operational practices at an high proficiency level.
- Experience managing incoming inspection programs, equipment control processes (including calibration and maintenance), environmental monitoring programs (viable and non-viable) including data analysis and trending, and support sterilization, endotoxin process analysis to ensure compliance with regulatory and quality requirements.
Pay and benefits
$102,480 – $163,968 a year
Employer providedPhilips Transparency Details
- The pay range for this position in Bedford, MA is $102,480 to $163,968.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
Generous PTO
7%
401k with up to 7% match
HSA with company contribution
Stock purchase plan
Education reimbursement
Annual incentive bonus
Where you'll work
Bedford, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Bedford, MAWorking conditions
Job Title
Senior Quality Operations Engineer
From the posting
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Learn more about our culture.
Additional Information
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
- Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA.
- May require travel up to 10%.
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 38% above the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Senior & Principal roles in the US20 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $102,480 | — | $163,968 |
| All US (middle half) | $93,000 | $96,500 | $113,000 |
This role: Philips's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 98 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Philips's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk10
- Collaboration and leadership9
- GMP and compliance5
- Lab testing and methods4
- Validation and qualification4
- Investigations and CAPA3
- Documentation and SOPs2
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- 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
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- 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 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- 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
Company hiring pulse
Philips on Regulatory Jobs
- 31
- Open roles
- 31
- Distinct roles
- 13
- Locations
By discipline
- Quality24 77%
- Clinical4 13%
- Regulatory3 10%
By level
- Senior & Principal15 48%
- Associate & Specialist8 26%
- Manager5 16%
More roles at Philips
- View role
Senior Quality Operations Manager-Ultrasound
Reedsville, PA · HybridManagerMedical Devices$120K–$190K
- View role
Senior Quality Operations Manager-Advanced Imaging
Bedford, MA · HybridManagerMedical Devices$134K–$213K
- View role
Intern - Regulatory Affairs
Orlando, FLAssociate & SpecialistMedical Devices$50K–$60K
- View role
Clinical Scientist – Computed Tomography
Orange, OHSenior & PrincipalMedical Devices$101K–$162K
Similar Quality Operations & Batch Release roles elsewhere
- View role
QA Operations Lead - 3rd Shift
AlconFort Worth, TXSenior & PrincipalMedical DevicesSalary not listed
Senior Quality Operations Engineer at Philips
Open until filled. $102K–$164K a year, employer provided.