Device & Combination Product Development Quality Engineer

Location: 

Basel Area - Allschwil, BL, CH

 

 

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we will develop Idorsia into one of Europe’s leading biopharmaceutical company, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 600 highly qualified specialists dedicated to realizing our ambitious targets.

 

Job Responsibilities

  • Accountable and responsible for Quality engineering product & process development from concept to market launch.
  • Provide sound Quality expertise to develop new product and timely address quality resolution for devices, combination product and packaging, and implement end to end effective control strategy and operational control plan.
  • Execute all Quality Engineering activities & tasks defined for the product including GMP & ISO documentation management internally and at suppliers, support to Regulatory filings and maintaining inspection readiness.
  • Oversight and manage Quality Assurance and Quality Control at device suppliers and tests service providers.
  • Responsible for the development, implementation and validation of all test methods required to effectively functionally characterize products.
  • Ensure qualification of Combination Product assembly process internally for clinical phases.
  • Effectively collaborate with all project functions and communicate quality requirement for industrialization of the product.
  • Maintain an overview of applicable quality standards and their evolution within the related business.
  • Ensure compliance with all local, state, federal, and Idorsia quality policies, procedures and practices, safety regulations, policies, and procedures.

 

Candidate’s Requirements

  • Undergraduate degree in related quality engineering field, advanced degree desired.
  • Minimum 7 years of experience in quality engineering or technical combination product development & industrialization with 5 years in medical or pharmaceutical industry
  • Successful track record of delivering products to market.
  • Demonstrated medical device, combination product and packaging development quality engineering skills.
  • Broad and deep understanding of disciplined quality product development processes, regulatory, and quality / risk management systems (ISO 13485, MDR, 21CFR820, ISO14971…)
  • Demonstrated supplier quality management skills.
  • Advanced Problem-solving skills and statistical knowledge
  • Advanced skills in method validation
  • Experience in leading a team

 

What Idorsia offers

  • Exciting opportunities for development and professional growth within our dynamic organization.
  • A collaborative and solution-oriented environment where you can make a difference.
  • An innovative and open culture in a truly multicultural environment.
  • A competitive salary and generous social benefits.

 

Work  Location: Allschwil

Country: Switzerland

Business Area: Pharmaceuticals Development

Schedule: Fulltime

Job Type: Permanent

Job ID: 1049

 

If you are interested, please click on apply now.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly-controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.