Jobs in life sciences

Quality officer (IVD medical devices)

Ref. 181
Function: The Quality Officer (QO) is responsible for implementation, maintenance and continuous improvement of the organization’s QMS (IVD medical devices).
Location: Zwijnaarde

The company:

The company's technology makes it possible to detect protein markers at a consumer price-tag with the ease-of-use of a pregnancy test and with clinical lab performance. The system comprises of a small read-out device and disposable tests. The tests rely on antibody-antigen reactions on silicon photonics technology, combined with microfluidics. 

Job description:

Role

The Quality Officer (QO) is responsible for implementation, maintenance and continuous improvement of the organization’s Quality Management System (QMS). The Q officer will report to the  QRA & Market Access Manager who remains accountable and responsible for the development of the quality strategy and is the company’s representative for regulatory and quality compliance during design, development, verification, validation and manufacturing of IVD medical devices to ensure a high level of process and product quality.

Main responsibilities

  • Coordinate the development, implementation and continuous improvement of the Antelope Quality Management System (QMS) to meet necessary regulatory requirements for In Vitro Diagnostic Medical Devices (IVD), such as the European IVD Regulation (2017/746), ISO13485, and the FDA Quality System Requirements (21 CFR 820).
  • Coordinate, support, review and follow up the required validation efforts, such as Equipment Qualification (e.g. IQ/OQ/PQ), Computerized System Validation (software tools and medical device software) or Process Validation.
  • Ensure continuous improvement, accuracy and maintenance of the Electronic Documentation Management System (EDMS); act as primary contact in the support (internal and external) and control its validated status
  • Plan, organize, prepare, conduct and follow-up internal Audits
  • Handle and follow-up Problem Report towards the QMS and as applicable, initiate and follow-up of corrective and preventive actions
  • Handle and follow up Change Control Reports towards the QMS
  • Provide training and ongoing mentoring to team members on the Quality Management System
  • Support in the compilation and (independent) review as applicable, of the Product Design History Files (DHF)
  • Support critical supplier audits, as deemed necessary
  • Organize, prepare, conduct and follow-up the QMS management review & analysis of data, and compile Key Performance Indicators. 
  • Report progress on continuous improvement programs.

Back-up responsibilities

  • Dialogue / interact with External Certification Bodies 
  • Act as a primary contact when 3rd party audits take place on-site
  • Provide quality assurance inputs to team members and promote awareness in terms of customer requirements.

Requested competences and skills:

  • Master’s degree in Life Sciences (e.g. Pharmacy, Biochemistry, Bio-engineer, Engineer) or equivalent by job expertise/training
  • Knowledge of the ISO 13485 standard and other quality standards, as applicable in the (IVD) medical device industry (e.g. ISO 14971, IEC 62304, IEC 62366)
  • 2-5 years in a Quality function within a related field (lab, pharma, medical device) 
  • Solid understanding of Quality environment related to medical devices, esp. IVD; or alternatively to pharma (GMP)
  • Experience with development of (IVD) Medical Devices is added value
  • Experience with equipment qualification, computerized system validation and/or process validation activities 
  • Experience in the maintenance of a quality management system, and implementing Quality improvements projects
  • Experience with Quality Software Tools
  • Experience in the Design Control and Risk management processes is an added value
  • Experience of quality system auditing
  • Knowledge of the FDA regulatory track and standards applicable thereto is an added value
  • Dutch and English language and written skills.
  • Excellent interpersonal skills and communication skills, written and oral, in English
  • Organizational skills
  • Highly analytical and attention to detail
  • Ability to think and adapt to a rapidly changing environment and demands
  • Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook).
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