Senior Quality Engineer
AutoStream Global are partnering up with multiple global leaders in the pharmaceutical, medical device and biotechnology industry. This particular company is looking for a Senior Quality Engineer that can be situated in on of their sites in Switzerland.
- Supervision of Quality Technicians and Quality Engineers.
- Drive and implement process improvements to ensure predictable processes across all product lines.
- Provide effective and responsive QA support to Operations to meet their area's objectives of
- Drive and implement plant wide quality system improvements.
- Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies.
- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
- Approval of change requests for product, process, and quality system changes.
- Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols, and reports approval.
- Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirement.
- Support the implementation of Lean Manufacturing across the site.
- Requires a minimum level 8 relevant Engineering / Science degree
- Excellent interpersonal and communication skills with good leadership abilities.
- Ability to work as part of a team and meet targets/goals efficiently.
- Excellent analytical and problem-solving skills.
- Minimum of 4+ years' experience within the medical device or pharmaceutical manufacturing industry.
- Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.
- Strong German language would be helpful but is not imperitative.