Training Operations Specialist - MedTech

Operational Specialist – Manufacturing & Training (MedTech)

Location: Leiden, Einsteinweg

Duration: End of 2026 

Hours: 40 hours per week, full time on-site

Imagine your next project supporting operations training, manufacturing procedures, and operator certification programs within a leading medical device environment.

We are seeking an experienced Operational Specialist with a strong MedTech manufacturing background. This role partners closely with Manufacturing, Quality, Engineering, and Regulatory teams to ensure operators are properly trained, certified, and compliant with GMP and quality system standards. The ideal candidate brings hands-on experience from leading medical device organizations such as Abbott Laboratories or Boston Scientific and understands the regulatory, quality, and compliance requirements governing medical device production.

roles and responsibilities.

As an Operational Specialist, you will develop, implement, and maintain structured operator training and certification programs while ensuring documentation aligns with quality system and audit requirements.

This will involve:

• Develop, implement, and maintain structured operator training and certification programs.

• Create skill matrices and qualification pathways for production operators.

• Conduct hands-on training sessions for new hires and cross-training for existing employees.

• Evaluate operator competency through assessments, observations, and re-certification processes.

• Ensure training documentation aligns with quality system and audit requirements.

• Develop, review, and update SOPs, work instructions, and manufacturing procedures.

• Collaborate with Engineering and Quality to ensure process documentation reflects validated manufacturing practices.

• Support change management activities related to process updates.

• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and internal quality standards.

• Support Lean manufacturing and continuous improvement initiatives.

• Identify training gaps and implement corrective actions.

• Assist during internal and external audits by providing training records and certification documentation.

• Drive standardization of best practices across manufacturing operations.

• Work closely with Production Supervisors, Quality Engineers, and Process Engineers.

• Support new product introductions (NPI) by preparing training materials and certification plans.

• Act as a subject matter expert (SME) for manufacturing training systems.

how to succeed.

You will bring a process-driven and structured approach with 5+ years of experience in medical device manufacturing and a strong knowledge of GMP, ISO 13485, and FDA regulations.

You will also bring:

• Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).

• 10+ years of experience in medical device manufacturing.

• Direct experience supporting operator training and certification programs.

• Strong knowledge of GMP, ISO 13485, and FDA regulations.

• Experience working in regulated environments similar to Abbott or Boston Scientific.

• Excellent documentation, communication, and organizational skills.

• Experience with Learning Management Systems (LMS).

• Lean / Six Sigma certification.

• Experience supporting audits and regulatory inspections.

• Background in catheter-based, implantable, or sterile medical device manufacturing.

• Strong attention to detail and compliance mindset.

• Ability to coach and mentor manufacturing personnel.

• Cross-functional collaboration skills.

• Continuous improvement orientation.

details.

This role offers a very competitive hourly rate. This contract will run until the end of 2026. This is an on-site position.

you are welcome here.

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

application process.

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

Diversity, Equity & Inclusion.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.