STAAR Surgical is a fast-growing international medical device company. Dedicated solely to ophthalmic surgery for over 30 years, we design, develop, manufacture and market innovative and high-quality ophthalmic implants with companion delivery systems.
Our company is further expanding by setting up a brand-new manufacturing site in Nidau BE, Switzerland and is therefore seeking a professional (f/m) as:
Quality Control Lead 100%
In this position you will work across multiple tasks and priorities within the Quality Assurance Team:
- Lead and coordinate Quality Control team member(s) engaged in inspecting incoming materials, in-process components, and finished products to ensure adherence to documented procedures, work instructions, blueprints, company quality standards and customer specifications.
- Lead and support batch record review/release to assure that in-process and finished goods were manufactured according to procedures and meet all specifications and documentation requirements.
- Coordinate the QC team to ensure a timely completion of all testing, including raw materials, in-process, final release,
- Ensure that the employees are properly trained, cross-trained and/or qualified and that the training records are up to date.
- Monitored the manufacturing and quality environments by review of the temperature and magnehelic charts and logs
- Lead and support execution of quality control related design control and validation protocol activities as assigned by protocol author
- Coordinate administrative and control activities for nonconforming materials or processes and process/product deviations (DEV.) to ensure compliance with internal procedures and external requirements and to assure product safety. Assign numbers and complete initial actions for Supplier Corrective Request (SCR)
- Mentor, coach, and develop Quality Control Inspectors; develop training plans.
- Interface with external auditors (Notified Body, FDA, etc.) during audits; participate in the preparation and completion of corrective action plans as needed.
- Experience in Quality Control with at least 3 years’ experience in the medical device industry, including practical application of FDA Quality System Regulation and ISO 13485 or equivalent.
- General knowledge of manufacturing processes such as injection moulding, assembly, packaging and sterilization required.
- Inspection and clean room experience is highly desired.
- Excellent supervisory, organization, writing and presentation skills.
- Very good English skills, both spoken and written.
- Good German and/or French skills, both spoken and written
- Ability to work under pressure and to prioritize and manage multiple tasks at the same time.
- Dedication to high quality and motivation to work in an international and dynamic environment.
If you want to contribute to the Evolution in visual freedom™ and become part of our passionate professional team, apply now! A great job experience and career development opportunities in an innovative medical device company is waiting for you!
Noemie Ohayon, HR Manager Swiss Operations, is looking forward to receiving your full application in English by e-mail: firstname.lastname@example.org.