R&D Quality Assurance Lead

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);

Primary tasks and 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.