Vacature Staff Quality Engineer

Staff Quality Engineer

• Titel Staff Quality Engineer
• Functie Engineering
• Sub functie Quality (Eng)
• Locatie Leiden, South Holland, Netherlands
• Gepost dec 18 2023
• Referentie 23W

Beschrijving

Mentor Medical Systems BV is known worldwide as a world-class manufacturer and supplier of medical products. We offer a position in a fast growing, diverse and international organization as we are part of the big American pharmacist Johnson & Johnson since 2009. The company's headquarters are located in Irvine, California (USA). We, as Mentor Leiden, develop and produce high-quality breast implants that are used in plastic surgery.

The department:

The department consists of a highly engaged team that is responsible for a wide area impacting the entire manufacturing site. This includes tasks that range from the production of new products to the evaluation of customer feedback. We support the introduction of new equipment, software and process changes on the manufacturing floor together with the partners from other departments on the site.

Job summary

Use Quality Engineering principles to develop, optimize, and support systems and processes that are aligned with the overall company strategy and mission affecting continuous quality improvement. . This start from new product development transfers, new equipment or process introductions, risk management, investigations as well as many other varying tasks.

Duties & responsibilities

• Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of Mentor products this includes product design and development, manufacturing, purchasing and improvements.
• Use statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development.
• Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities.
• Reviews and approves validations documentation (eg. IQ, OQ, PQ and verification studies).
• Leads or is team member of CAPA and Audit investigation and action plans.
• Investigate instances of nonconforming material and supports the determination of the cause and corrective actions to be implemented
• Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations.

Kwalificaties

More than 3 years with Pharmaceutical/Medical Device companies

Bachelor's degree (B.S.) in engineering, science, mathematics or statistics is required. Master's degree in engineering, science or mathematics is preferred;

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS .

• Pro Active
• Solving and Risk Assessment / Risk Management minded
• High level of accuracy
• Flexible and Service minded
• Able to identify and simplify complex issues
• Interpersonal skills
• Proficient in English
• Six Sigma Blackbelt or Greenbelt certifications are preferred

Johnson & Johnson family employers value diversity and inclusion. We are committed to building diverse teams that reflect the patients and partners we support. We strive to create an inclusive work environment where our people feel at home and have the space

De werkgevers van de Johnson & Johnson-bedrijvengroep streven gelijke kansen na voor iedereen. Alle sollicitanten die de juiste kwalificaties hebben, worden zonder onderscheid te maken voor wat betreft ras, kleur, religie, geslacht, seksuele voorkeur, genderidentiteit, genetische informatie, land van oorsprong, beschermde veteranenstatus, handicap of ander kenmerk dat wettelijk wordt beschermd, in overweging genomen voor vacatures.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

Functie:	staff quality engineer
Startdatum:	21-12-2023
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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