New · posted Nov 12
Johnson & Johnson · Medical Devices
Sr Manager Surgery Quality & Compliance (Q&C) Transformation Lead
- Raritan, NJ
- Hybrid
- Full-time
- Manager
The role
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Johnson & Johnson is currently seeking a Sr Manager Surgery Quality & Compliance (Q&C) Transformation Lead to be located in Raritan, New Jersey. This is a duration-based project expected to conclude on December 31, 2028.
Confirmation & validation of initiatives
- Establish an accurate, validated portfolio baseline and ensure all initiatives are documented and ready for execution.
- Serve as the primary point of contact between the BU and the Optimize PMO
- Partner with Program Leads, S&D Leaders, and initiative DRIs to gather and validate initiative information
- Maintain the BU portfolio tracker / PMO tool so all initiative records stay current
- Member of OnePlan implementation team
- Follow up with DRIs for status, savings estimates, assumptions, timing, and supporting documentation
- Drive resolution of missing information, data quality issues, and validation gaps
- Confirm annual savings and investment phasing by year
Execution & value realization
- OnePlan SPOC for BU/COE
- Drive portfolio execution, proactively manage risks, and ensure benefits are realized and reported accurately
- Support the development & implementation of the Total Cost of Quality program and serve on the CoQ workstream.
- Monitor execution of all initiatives within the BU portfolio
- Track milestone completion and overall project health
- Run regular reviews with project teams on status, risks, dependencies, and mitigation plans
- Update scope, timelines, savings, investments, and resource changes as initiatives evolve
- Ensure projects comply with required stage-gate and governance processes
- Record actual savings and investments and align to financial reporting
- Escalate risks and partner with owners on mitigation and recovery plans
- Financial Acumen is a needed capability.
- Drive/ Lead program and individual projects including communication, execution, deliverables tracking, deployment and escalation to leadership
- Planisware tracking & updates for programs
- Track G&O and it’s execution across portfolio
- Business acumen and negotiation
Other
- Up to 10% travel may be required.
- Candidates must already have authorization to work in the country of employment. Immigration sponsorship and relocation support are not available for this position.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
What you need
Qualifications / Requirements
- An undergraduate degree in Engineering, Science, Business, Business Management, or Quality Systems Management is required. A graduate degree is preferred.
- Minimum of 10 years of related work experience; 2+ years of leadership experience in Quality Assurance within Medical Device, Diagnostic, Pharmaceutical, or other regulated industries.
- Project Management experience.
- Critical thinking and investigative skills.
Preferrednice to have
- Experience in international Medical Device regulations.
- Knowledge and experience in portfolio management and project execution.
- Cross-functional (matrix) project management expertise with strategy development, planning, and corresponding measurable business results.
- Understanding the interdependence of product development, manufacturing, and delivery to the customer.
- Demonstrated track record of creating and maintaining strong relationships across multiple disciplines.
- Driving alignment and consensus with project teams; ability to achieve results collaboratively.
- Leadership across diverse organizations in terms of scope, experience, and geographic presence.
- Demonstrated success in managing complexity.
Preferred Skillsnice to have
AI solution evaluation, Budget Management, Business Process Management (BPM), Business Requirements Analysis, Compliance Management, Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Inclusive Leadership, ISO 9001, Leadership, Process Governance, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Standard Operating Procedure (SOP), Strategic Thinking, Tactical Thinking, Team Management
Pay and benefits
$127,000 – $218,500 a year
Employer providedThe anticipated base pay range for this position is
$127,000.00 - $218,500.00
Pension and 401(k) savings plan
Long-term incentive program
Vacation (120 hours per year)
Sick time
Holiday pay (13 days)
Parental leave
Where you'll work
Raritan, NJHybridOpen in Maps (opens in a new tab)
More jobs in Raritan, NJWorking conditions
Job Function
Quality
Job Sub Function
Business Process Quality
Job Category
People Leader
All Job Posting Locations
Raritan, New Jersey, United States of America
From the posting
About Johnson & Johnson
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
Additional Description for Pay Transparency
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 16% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in New Jersey7 roles publishing pay
Manager roles in the US57 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $127,000 | — | $218,500 |
| New Jersey (middle half) | $113,000 | $139,000 | $157,500 |
| All US (middle half) | $120,000 | $149,000 | $166,000 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 336 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 42 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Documentation and SOPs6
- Validation and qualification4
- GMP and compliance3
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirementsNamed 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
- 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
- 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
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- 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
Johnson & Johnson on Regulatory Jobs
- 42
- Open roles
- 42
- Distinct roles
- 17
- Locations
By discipline
- Quality25 60%
- Clinical9 21%
- Regulatory8 19%
By level
- Senior & Principal16 38%
- Manager15 36%
- Associate & Specialist6 14%
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Sr Manager Surgery Quality & Compliance (Q&C) Transformation Lead at Johnson & Johnson
Applications close November 18. $127K–$219K a year, employer provided.