New · posted Nov 10
Johnson & Johnson · Medical Devices
Senior Manager, Quality Systems
- Añasco, PR
- On-site
- Full-time
- Manager
The role
Lead the design, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) to ensure compliance with applicable regulations and corporate quality standards.
Act as a subject matter expert for Quality Systems across development, manufacturing, and supply chain activities, enabling product quality, patient safety, and regulatory readiness.
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.
Other
- Travel: occasional to domestic sites/suppliers and regulatory inspections (as required).
- This role requires demonstrated integrity, adherence to compliance standards, and the ability to operate in a regulated environment.
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.
We are searching for the best talent for Senior Manager, Quality Systems to be located in Añasco, PR.
What you need
Required
- Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
- A minimum of 8 years of progressive experience in quality systems within pharmaceutical, biotech, medical device, or regulated industries.
- In-depth knowledge of cGMP, 21 CFR Part 210/211/820 (as applicable), ISO 13485 (if medical device), ICH Q10, and other relevant regulations and guidance.
- Proven experience with eQMS platforms (EtQ, TrackWise, etc) and quality metrics/reporting tools.
- Experience with change control or PLM systems (Agile, Windchill, etc.).
- Strong experience in CAPA management, root-cause analysis techniques (5 Whys, RCA, fishbone), and investigation governance.
- Demonstrated experience leading audits and interacting with regulatory inspectors.
Preferrednice to have
- Experience with Lean, Six Sigma, or continuous improvement methodologies; certification preferred.
- Prior experience in supplier quality management and audit programs.
- Familiarity with validation strategies for processes, equipment, and computerized systems.
- Experience leading cross-functional change control and product transfer activities.
- Strong leadership and people management skills; ability to influence without authority.
- Excellent written and verbal communication; able to present to senior leadership and cross-functional teams.
- Analytical thinker with strong problem-solving skills and attention to detail.
- Project and stakeholder management skills; able to prioritize and deliver results in a matrix environment.
- Commitment to building a culture of quality and compliance.
- Office and manufacturing floor presence required; PPE and site access per safety protocols.
Preferred Skillsnice to have
AI solution evaluation, Collaboration, Compliance Management, Consulting, Corrective and Preventive Action (CAPA), Data Quality, Developing Others, Incident Management, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, System Integration, Systems Analysis, Tactical Planning, Team Management
What you'll do
- Own and continuously improve the QMS (policies, SOPs, work instructions, records) to align with cGxP expectations and corporate requirements.
- Lead CAPA, nonconformance, deviation, change control, complaint handling, and recall readiness processes; ensure timely investigation, root-cause analysis, and effective remediation.
- Develop and maintain a risk-based approach to quality (FMEA, QRM) and integrate risk management into product and process decisions.
- Oversee internal and supplier audit programs; plan, coordinate, and lead internal and external audits and ensure timely closure of findings.
- Support supplier qualification and ongoing supplier quality oversight, including audits, performance monitoring, and corrective actions.
- Ensure effective document and record control, release processes, and electronic QMS (eQMS) utilization and optimization.
- Provide quality support for manufacturing transfers, scale-up, technology transfers, and process validation/changes.
- Coach and mentor site quality teams and cross-functional partners on quality system expectations, investigations best practices, and compliance culture.
- Prepare and present quality metrics and dashboards to site leadership; drive data-driven continuous improvement.
- Interface with regulatory agencies during inspections and regulatory submissions as required.
- Manage, hire, and develop direct reports (if applicable); foster a culture of accountability and continuous learning.
Where you'll work
Añasco, PROn-siteOpen in Maps (opens in a new tab)
More jobs in Añasco, PRWorking conditions
Job Function
Quality
Job Sub Function
Quality Systems
Job Category
People Leader
All Job Posting Locations
Anasco, Puerto Rico, 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
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 10, 2026
Salary intelligence
How the pay compares
Manager roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $140,125 | $159,250 | $169,250 |
Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 91 open Quality Systems & Document Control 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 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk20
- GMP and compliance12
- Collaboration and leadership10
- Investigations and CAPA4
- Documentation and SOPs3
- Validation and qualification3
- Lab testing and methods2
- Data and digital systems2
- Regulatory submissions1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control 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
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- 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
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 34
- Open roles
- 34
- Distinct roles
- 15
- Locations
By discipline
- Quality16 47%
- Regulatory9 26%
- Clinical9 26%
By level
- Manager13 38%
- Senior & Principal11 32%
- Director5 15%
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Senior Manager, Quality Systems at Johnson & Johnson
Applications close November 17.