Engineer, Quality Engineering

Description

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 https://www.jnj.com

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Job Description:

Job Description:

AMO Groningen is recruiting a QA Engineer, located in Groningen.

The QA Engineer ensures that systems and equipment within the Mechanical and Optical Laboratory (MO Lab) are adequately maintained and remain in a compliant state. The QA Engineer contributes to the development of high-quality products by developing and improving laboratory testing methods. The role involves close collaboration with R&D, QA, and Technical Services, and supports non-conformance and CAPA processes.

Key Responsibilities:

• Evaluate compliance with applicable laboratory standards and procedures;

• Act as a Subject Matter Expert (SME) during projects, regulatory, medical device (MD), and notified body audits and inspections;

• Improve and maintain laboratory procedures;

• Specify, develop, and improve test method validations, including writing protocols and reports;

• Write and develop IQ and TMV protocols and reports for new and existing laboratory equipment;

• Act as a project leader for laboratory-related projects;

• Participate, when necessary, in cross-functional projects and activities;

• Coordinate non-routine laboratory testing activities, including validation testing;

• Manage internal audit observations, Non-conformance and CAPA records from initiation through full cycle completion and final approval;

• Make recommendations to improve product quality, efficiency, cost, processes, and productivity techniques;

• Support day-to-day laboratory troubleshooting for test equipment and unexpected test results;

• Gather and analyze test result data;

• Lead Cost Improvement (CIP) projects;

Qualifications

Education:

Bachelor or Master degree preferably in mechanical engineering, optical engineering mechatronics, and relevant technical disciplines.

Experience and Skills:

Minimum of 4 years of related experience within Pharmaceutical and/or Medical Device companies.

Other:

• Advanced, broad, and in-depth knowledge of laboratory testing and automation;

• High level of accuracy and attention to detail;

• Strong troubleshooting and analytical skills;

• Strong planning skills with the ability to prioritize multiple commitments and solve technical problems;

• Good interpersonal skills, with the ability to engage effectively with personnel at all organizational levels;

• Writing skills, ability to create protocols, reports, business correspondence, and procedures;

• Proactive and able to work independently,

• Skilled to develop and present new or improved test methods and solve laboratory problems in a timely manner;

• Fluent in Dutch and English;

• Ability to work with various measuring equipment.

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.

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.

The anticipated base pay range for this position is 44,700 to 70,840 EUR.

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