The Senior Quality Engineer is an experienced professional responsible for leading quality assurance initiatives within the Global Engineering Technology, Project Execution (GET-PEx) organization. This role ensures that processes and systems consistently meet or surpass customer expectations, regulatory standards, and industry benchmarks. The Senior Quality Engineer plays a vital role in driving continuous improvement, managing complex quality challenges, and mentoring team members on quality topics. As a technical expert and quality leader, the focus is on enhancing product reliability, reducing defects, and optimizing processes to achieve operational excellence.
Responsibilities
- Collaborate with cross-functional teams (Operations, QC, QA) to analyze and resolve quality issues. Communicate and escalate concerns promptly to management.
- Lead investigations into non-conformances and CAPAs, including risk assessments, root cause analysis, and the successful implementation of corrective and preventive actions.
- Support GMP training compliance by maintaining the GET-PEx curriculum matrix, preparing updates, and assisting management in content review and periodic assessments.
- Serve as the primary contact for internal and external audits/inspections, coordinating support from the GET-PEx department.
- Develop and maintain weekly and monthly quality metrics related to GMP training, document reviews, non-conformance, and CAPA tracking. Investigate and remediate identified issues.
- Act as the record coordinator for the GET-PEx department, advising on record management, including archiving physical records and ensuring data integrity.
- Promote quality awareness within the department by sharing relevant topics to reduce recurring issues.
- Work independently with minimal supervision to meet tight deadlines while ensuring compliance with all company policies and procedures
Functie-eisen
- At least 4 years of proven experience in the (bio)pharmaceutical industry or related academic background.
- Minimum of 2 years supporting quality functions, including NC/CAPA management, GMP training, and document/record management.
- Excellent verbal and written communication skills in English, capable of engaging effectively with internal and external stakeholders up to the departmental management level.
- Experience with risk management tools (e.g., FMEA, HACCP) and root cause analysis techniques (e.g., 5-Whys, Kepler-Tregoe, Ishikawa).
Other Requirements
- Ability to present and defend departmental quality assurance practices and findings to senior management (e.g., SLT, ECB, CCB).
- Strong analytical thinking skills, with the ability to handle complexity, ask insightful questions, utilize data effectively, identify gaps, and develop creative solutions.
- Proficiency in computer applications such as MS Office, Tableau, and eDMS
Arbeidsvoorwaarden
- Duration: 1-year contractor role with potential for extension.
- One-year contract with the intention to offer a permanent contract afterward.
- Discount on the collective health insurance plan via Zilveren Kruis.
- Access to the Yacht network of companies and industry specialists.
- Generous referral program – up to €1,500.
- Attractive pension scheme (STIPP).
- 8.33% holiday allowance.
- Commuting reimbursement – €0.23 per kilometer up to 26km one way.
- Soft skills coaching – you’ll be assigned a coach (if desired) from your professional field to spar with and guide you. Additionally, you’ll have a dedicated Yacht contact person to help shape your career ambitions and create a development plan together
Two interview stages via Teams:
- First with hiring manager and a colleague.
- Second with another colleague.
Shortlisting Wednesday Morning
Notice period: Ideally less than 2 months; 1 month is acceptable.
Bedrijfsinformatie
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where sophisticated diseases are prevented, treated, and cured, where treatments are more inquisitive 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.
YACHT Life sciences
Yacht is a leading Dutch recruitment and secondment agency that connects highly skilled professionals with forward-thinking organizations. As part of Randstad Group Netherlands,Yacht Life Sciences, is a leading talent partner in the Dutch Life Sciences, Pharma, and Biotech sectors. Yacht connects ambitious professionals with impactful roles at top organizations such as Astellas, Danone, Philips, and Johnson & Johnson.
Operating in one of the fastest-growing industries in the Netherlands, Yacht Life Sciences offers both project-based assignments and permanent positions that contribute to the development of medical devices, therapies, and medications aimed at improving global health.
Professionals working with Yacht benefit from:
- Access to a strong network of industry experts and innovative companies.
- Opportunities to participate in R&D projects, clinical studies, and quality & regulatory initiatives.
- Continuous development through training, courses, and knowledge-sharing events.
- A personalized career path shaped by your ambitions and supported by dedicated coaches and consultants.
Contactinformatie
Voor meer informatie neem contact op met Nicole Miggels 06-13897074
Een baan via Yacht Engineering
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? We geloven dat diverse teams van belang zijn voor ons als lerende organisatie die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag!
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Ritika Agarwala
ritika.agarwala@yacht.nl
06-40981171
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