Test & Quality Engineer Medical Device - Switzerland
Want to know company name or location? Company managed [?]
- Our company is a research-driven, specialty biopharmaceutical group active in global markets.
- The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Our company has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.
- Responsible of quality and test activities for marketed device products – both at our company and at subcontractors. Maintenance and review of the technical files.
- Responsible for the design verification activities and equipment to verify design changes and for process validation activities (including revalidation) for manufacturing processes and test methods at subcontractors or within the company Manufacturing Network.
- Lead change control activities internally or at subcontractors using QA-Track tool.
- Coordinate implementation of change linked to Regulatory assessment
- Driving the establishment of Technical Agreements with the subcontractors.
- Responsible to establish Quality KPI and to track quality performance of the subcontractors.
- Review and approve documents from the subcontractors.
- Perform internal and external quality audits.
- Maintain the technical file documentation including the risk management file for products where company is the Legal Manufacturer or for device parts of Combination Products in the US Market.
- Participate to develop and maintain the Quality system supporting activities needed according to Regulatory and Quality Standards.
- Participate in cross functional teams to create and implement manuals, guidelines, tools to facilitate and structure working processes within the company.
Required Experience & Skills
- Degree in Mechanical or micro technical Engineering or equivalent.
- Minimum 3 years’ experience in medical device design and manufacturing industry with demonstrated quality support experience.
- Good working knowledge within Medical Device design control and manufacturing, including EU and FDA regulation preferred.
- Good written and documentation skill.
- Excellent command of English (verbal & written).
- Good communication (both written/verbal) and listening skills; an ability to persuade others by using evidence (facts and figures) to justify arguments;
- Ability to represent the business to the customer/external stakeholders.
- Certified Internal/external auditor.
- Ability to work well as an integral part of a large Project Team, a team player, task oriented and keen on working in a cross-cultural working environment.