Обява Премиум

Quality Assurance Lead/Representative

A client of ours that specializes in the development of an R&D center for medical devices is looking for a Quality Assurance Representative. This person would occupy a key position within the organization, based in Sofia. The position holder will ensure the implementation of quality standards, according to all regulation requirements applicable to medical device manufacturing. He/she ensures QA support and supervision of QA-related activities to the R&D department, ensuring the product development follows all quality requirements and meets applicable quality standards throughout the processes and up to the customer.

Reporting line and team:

  • Direct reporting line to Head of RD Sofia;
  • Dotted line to QA department, based abroad;
  • External and internal stakeholders;
  • R&D team members;
  • QA department (Base Unit in Prague);
  • Manufacturing fields (Plovdiv/Benesov);

Responsibilities:

  • Guarantor of the proper process or procedure execution;

  • The QA representative shall ensure that the RD processes follow the corresponding SOP (SOP-05);

  • Helping the team to understand and comply with the Standards regulating the specific industry during the design and development process;

  • Helping in preparing up-to-date (in synchrony with the development process) documentation

  • (Note: the QA rep is not supposed to provide and deliver the documentation him/herself but to guide the team on what, how, and when to be provided)

  • Preparation for product transfer

  • Guiding the Project team from the RD to assure the proper quality outputs before the transfer process;

  • Guiding and synchronizing the team during the transfer process.

  • Cooperating with QAS in the acceptance party (the production factory) with the proper quality processes in the phase of the transfer

  • Guiding in process validation.

  • Participating in Process Risk Assessment

  • Working closely with the QA department to provide updates, changes, and news in the QMS;

  • QA partner for the local RD team with the details, main needs, and goals;

  • Learn the news of the standards (updates, amendments, and changes);

  • To assure that the team understands the changes and the accountability in future projects or the actual effect of the changes to the current design process;

  • Supports the team to perform product changes. (ECOs);

  • Supports the team in preparation for certification.

  • Prepares and manages the implementation of action plans;

  • Performs internal quality audits (RD dedicated);

  • Participate in external audits;

Qualifications and expertise:

  • A university degree or equivalent qualification in relevant sciences such as Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Material Science Biomedical; Engineering, Mechanical, Electrical or Electronic Engineering, etc.

  • Experience in quality assurance roles in manufacturing, medical devices, and/or pharmaceutical companies;

  • Knowledge and experience in quality management standards and systems;

  • Experience in project management;

  • Work in the medical devices industry or closely related industries (e.g. pharmaceutical industry) such as research and development, manufacturing, quality management, and regulatory affairs will be considered as an advantage;

  • Experience in a multinational environment;

  • Computer literacy: MS Office, PowerPoint, Excel. Experience with ERP systems;

  • Ability to plan, organize, and control his/her work;

  • Fluent English written and spoken;

Personal skills:

  • Excellent Communication skills;

  • Problem-solving and decision-making skills;

  • Analytical thinking;

  • Initiative, flexibility, ability to work under pressure;

  • Systematic, detail-oriented, and result-oriented;

  • Strategic thinking and strategic planning skills;

  • Team player.

What the company offers:

Food vouchers 200 BGN; Initial training; Flexible start of the working day; Health insurance; Christmas bonus; Marriage and childbirth bonus; Bonus for parents of first grades; Vouchers for sports and cultures; Location within the city; 1 week summer vacation; Extended Christmas and New Years holiday; Loyalty bonus; BTL medical device to use at home; Work in an international company with lots of opportunities for career growth.