Quality Assurance Manager Combination Products and Medical Device; temp

Quality Assurance Manager Combination Products and Medical Device (temp, 100%)

Direct message the job poster from Congenius AG.

Congenius provides tailored expertise and leadership to global firms, established SMEs and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the Med Tech industry, then joining our dynamic team could be your next rewarding career step.

• Act as the quality single point of contact for assigned device development or industrialization projects for combination products and medical device
• Ensure adherence to applicable design control and risk management requirements
• Collaborate across functions to ensure robust quality at the interface between the drug product and device component within the combination product
• Develop and deploy risk management plans and reports; actively participate in and facilitate FMEAs
• Define specifications, including the drug product–component interface
• Drive investigations and change control assessments
• Represent the department at quality and change review boards
• Advise and consult customers and suppliers (take indirect leadership as appropriate)

• Bachelor of Science (BSc) in life sciences discipline or chemical/mechanical engineering
• Professional background: 5+ years of experience in device quality or device development within the pharma or medical device industry
• Experience in project management in the pharma industry with tools Six Sigma / DMAIC is preferred
• Hands on expertise in applying risk management concepts and tools, and deploying design control for combination products
• Sound knowledge of cGMPs and relevant international regulatory requirements (QSR; MDR; ISO
  13485, etc.)
• Confident in presenting, networking, and building relationships
• Team player who works efficiently and flexibly within interdisciplinary teams in global environments
• Decision maker, taking the lead where appropriate and necessary
• Fluent in English – written and spoken, German is a nice to have
• This contract is limited to one year with an option for extension
• Work in Basel area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
• Benefit from flexible working hours and an exciting and versatile field of activity
• Work in a company with a flat hierarchy, short decision-making processes
• Expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
• Benefit from modern and attractive working conditions and development opportunities
• An attractive salary and very good social benefits round off the offer

Associate

Full-time

Consulting and Engineering

Business Consulting and Services, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Congenius AG by 2x.

Apply BELOW