Senior Quality Investigation Engineer

ppAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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. /p pAs 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. /p h3Job Function /h3 pQuality /p h3Job Sub Function /h3 pCustomer/Commercial Quality /p h3Job Category /h3 pProfessional /p h3All Job Posting Locations /h3 pSchaffhausen, Switzerland /p h3Job Description /h3 pWe are searching for the best talent for a bSenior Product Quality Investigation Engineer /b. /p h3Purpose /h3 pWe are looking for a Senior Product Quality Investigation Engineer to join our Product Quality Vigilance organization. /p pAre you interested in solving complex product quality challenges while working with manufacturing, quality, and regulatory teams around the world? /p h3You will be responsible for /h3 pIn this role, you will lead, conduct, and support Product Quality Complaint investigations for commercial and clinical products.

Working closely with manufacturing sites and multi‑functional partners, you will ensure investigations are complete, scientifically sound, and appropriately documented before complaint closure. You will serve as a key Product Quality Vigilance contact for assigned manufacturing sites, supporting investigation activities, complaint management processes, issue escalation, and product knowledge transfer.

The role also includes participation in failure investigations, Medical Device Reporting activities, and product trend evaluations. /p h3Additional Responsibilities Include /h3 ul liServing as a Product Quality Vigilance consultant for complaint investigations /li liLeading, conducting, and supporting end‑to‑end Product Quality Complaint investigations for Janssen combination products and drug products /li liCoordinating and supporting failure investigations and assisting with Medical Device Report submissions /li liActing as the Single Point of Contact (SPOC) for Product Quality Vigilance activities with Manufacturing Sites and supporting cross‑training activities across sites /li liPartnering with Manufacturing Sites to raise awareness of complaint aging, upcoming due dates, prioritization activities, and Medical Device Reporting requirements /li liSupporting complaint‑related site

escalations and communicating site issues and opportunities to end‑to‑end quality teams /li liParticipating in signal and trend evaluations related to site products /li liPerforming statistical and data‑based processes to support risk management activities and decision‑making /li liSupporting transactional activities related to complaint management, including DHR review, data collection, data correction, and data uploads /li liSupporting internal and external audits, inspections, and Health Authority requests /li liLeading Product Quality Vigilance projects and supporting new business initiatives to ensure effective complaint and knowledge transfer /li liProviding guidance on complaint handling requirements and supporting interpretation and implementation of applicable quality system requirements /li liFinding opportunities to improve investigation methods, complaint management

processes, and product knowledge sharing /li liEducating, training, and supporting colleagues on complaint investigation processes, product knowledge, and site‑specific processes /li liCreating and maintaining work instructions and standard operating procedures related to complaint investigations and complaint management activities /li /ul h3Requirements /h3 ul liBachelor’s degree in a technical, scientific, or engineering field required /li liMaster’s degree, MBA, or other advanced scientific or engineering degree preferred /li liMinimum 5 years of experience in Quality Assurance, Quality Control, Product Quality, or a related quality function /li liProven experience within the pharmaceutical, medical device, or another highly regulated industry /li liExperience in Complaint Management, Post‑Market Vigilance, Risk Management, or Compliance is preferred /li liPrevious project leadership

or supervisory experience is desirable /li liKnowledge of medical safety environments and applicable laws /li liExperience with complaint investigations, risk management activities, and product quality systems /li liAbility to support change initiatives, project activities, and collaboration across functions and sites /li liFamiliarity with applicable laws and standards, including 21 CFR Parts 4, 210, 211, 314, 803, 806, 820; ISO 13485; ISO 14971; ICH Q10; GDP; GMP; GVP; MEDEV 2.12; CMDR; and Medical Device Directive 93/42/EEC /li liStrong analytical, investigation, and problem‑solving skills /li liAbility to communicate optimally verbally and in writing /li liAbility to present technical information to multiple levels and departments within the organization /li liAbility to build strong working relationships in a global environment /li liGreen Belt (Six Sigma) or equivalent

investigation training is desirable /li liBlack Belt (Six Sigma) and/or ASQ Certified Quality Engineer (CQE) certification is preferred /li liDemonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity /li /ul h3What We Offer /h3 pWe offer a collaborative and inclusive environment where innovation, learning, and professional growth are encouraged. This role provides opportunities to work with global teams, contribute to meaningful quality initiatives, and support products that make a difference for patients around the world. /p h3Our commitment to inclusion /h3 pAt Johnson Johnson, we believe health is everything.

Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives. /p pWe are proud to be an equal opportunity employer and welcome applications from all qualified candidates. Employment decisions are made without regard to legally protected characteristics. /p pIf you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help. /p pPlease note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Italy, Belgium, Ireland - Requisition Number: bR- /b; Switzerland - Requisition Number: bR- /b; US - Requisition Number: bR- /b.

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. /p h3Required Skills /h3 pAudit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP) /p pPreferred Skills: Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP) /p /p