Sr. Quality Engineer in the Field Service Area in Heidelberg bei Bausch + Lomb

Bausch + Lomb

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 + Lomb 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. For Bausch + Lomb Technical Service, based at our surgical production site in Heidelberg, Germany (www.storzeye.de) we are looking for an experienced

Sr. Quality Engineer (m/f/d) in the Field Service Area

Key Responsibilities :

• Leading and overseeing all quality- and compliance-related activities in B+L field service area to ensure a smooth and efficient operation. Supporting the regional/ global quality strategies in B+L field service area
• Ensuring compliance with all applicable national and international regulatory requirements (e.g. ISO 13485, 21 CFR part 820, EU MDR, UK MDR, CH MedDO...etc.), as well as B+L SOPs and WIs in the field service area, in collaboration with internal and external stakeholders
• Participating and representing B+L field service as quality management representative (QMR) in internal and external audits, and leading the investigation and implementation of NC and CAPA
• Promoting quality and regulatory awareness throughout B+L field service area
• Leading/ supporting the continuous improvement initiatives to achieve operational excellence meanwhile ensuring compliance and a high level of quality

• More than 5 years of experience within Quality Management-Systems, preferable in the Medical Device Field
• Completed university or academic studies BE,BSC/ME,MSC
• Experience with MDR (EU) 2017/745; MDD 93/42/EEC Annex II (excluding section 4) and Annex V; EN ISO 13485; US Federal Regulations (21CFR Part 820); EU 2022 (Blue Guide); 2012/19/EU – WEEE2
• Excellent written and verbal communication skills in English with the ability to communicate in a multinational organization
• Strong personal management and Leadership skills

Bausch + Lomb offers a very interesting future-oriented work environment, a competitive salary, an international team within a renowned global player and the professional advantages of an environment that supports your development and recognizes your achievement.

There's no such thing as a typical day in our TSOC team.

Would you like to step into a quality position where you ensure a smooth and efficient field service operation? Are you motivated to achieve operational excellence meanwhile ensuring compliance and a high level of quality? We are looking for people like you to take the challenges and make a difference in the way we work.