Senior Quality Engineer job in Netherlands

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 the Netherlands.

Responsibilities:

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.

Qualifications:

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.
Dutch spoken would be helpful but not imperative.