ResponsibilitiesLocation Baesweiler, North Rhine-WestphaliaDE Job ID JR-030982
The global QA Team supports each PerkinElmer sites to maintain the highest standards of quality and compliance for our products. Your role will be to build close relationships with the site management team, global QA team, local authorities and wider PKI network to ensure that in vitro Diagnostic (IVD) products comply with global regulations.
- Minimum Bachelor’s Degree in Engineering / Science disciplines
- Experienced in Quality Management Systems in a design and manufacturing environment, preferably Medical Device industry.
- Experienced in Supplier Management, Product and Customer Quality.
- Experience in root cause analysis and using tools as SPC, DoE, capability studies, FMEA.
- Strong interpersonal, verbal and written communication skills, able to interact effectively with people at all levels, including top management as Management Representative and developing strong collaboration with regional leadership
- Strong knowledge and application in ISO 13485:2016 and IVDR. Experience with ISO 9001:2015, 21CFR820 and MDD also desirable.
- Listed as Person Responsible for Regulatory Compliance (PRRC)
- Fluent in German and English language.
Living the Perkin Elmer Values
As the global QA Team, we live the Perkin Elmer values within our role on a daily basis. They shape how we interact with other departments, our external partners & support our colleagues.
We take Ownership and Get it DONE
- Appointed as the Quality Management Representative for the site, ensure compliance to all relevant regulatory requirements.
- Maintenance and further development of the operational quality management system in all areas of the company
- Introduction, monitoring and maintenance of the quality policy & related documentation
Create Better Solutions for the Customer TODAY
- Stimulate cross functional collaboration to achieve better customer satisfaction.
- Develop goals and strategy plan to meet the company’s business objectives.
Passion for PEOPLE
- Instruction and training of the employees to implement the defined QA structures and processes
- Working with external partners, identify new opportunities for product collaborations.
Us Before Me, We are a TEAM
- Lead site quality initiatives to drive operation and product quality improvement.
- Support global quality system process integration, harmonization and simplification. Managing local implementation and changes.
Do the Right Thing ALWAYS
- Ensure effectiveness and compliance to ISO9001, ISO13485, 21CFR 820, GDPMD and various regulatory requirements (CE, NRTL).
- Identifying quality issues and assist in their resolution; processing of complaints & CAPAs.
Your advantages with us:
- Cooperative and diverse environment
- Individual programs for your personal & professional development as well as career opportunities
- A demanding, varied job in a globally successful technology company
- AXA group and travel insurance (also for private purposes)
- Company paid pension scheme
- Family friendly culture including additional holidays for big milestones and established work from home processes.
- Community responsibility, with volunteer days and corporate matching of employee charity donations.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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