Ensures that the Site Quality System is effective in meeting defined requirements and reports the performance to management as well as the compliance with applicable company, ISO, FDA and other regulatory and local policy requirements;...
Bausch + Lomb is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.
As a part of the Bausch Health Group the company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products.
Based at our surgical production site in Heidelberg, Germany (www.storzeye.de) we are looking for an experiencedSite Quality Manager (m/f/d)
Key Responsibilities:
- Ensures that the Site Quality System is effective in meeting defined requirements and reports the performance to management as well as the compliance with applicable company, ISO, FDA and other regulatory and local policy requirements
- Leads and oversees all Quality and Compliance functions for the Heidelberg manufacturing site, incl. site Quality budget, Quality planning, Quality resources and development of Quality personnel
- Counterpart for notified body
- Ensures external / internal QMS audits and supplier audits are conducted on a scheduled basis and ensures the effectiveness of corrective and preventive action
- On-site expert on Quality and Compliance providing input and support for the Regional / Global Quality Strategies
- Areas of focus include, but not limited to Re-/Validation, Re-/Qualification, CAPA system, nonconformance management, supplier quality management, implementation of regional and global requirements
Profile:
- Completed Degree in an Engineering or Natural Science
- 5 years medical device quality experience with EU MDD/MDR and US FDA
- Experience in communication with notified bodies and authorities
- Must possess at least an advanced level of performance in the majority of the following core competencies: influence key stake holders, business acumen, project management, relationship building, quality expertise
- Sound knowledge of the admission requirements according to MDD and MDR as well as
DIN EN ISO 13485 - Strong leadership skill
- Structured and thorough work attitude
- Advanced computing skills including Word, Excel, Outlook Email
- Excellent written and verbal communication skills in German and English
Bausch + Lomb offers a competitive salary, an international team within a renowned pharmaceutical global player and the professional advantages of an environment that supports your development and recognizes your achievement.
To apply for this position, please send your CV and covering letter in English to Doris.Volkwein@bausch.com
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