- October 3, 2022
- Successful Projects
QA/ QC Manager
Our client is Pharmaplast – a company that specializes in manufacturing advanced wound care dressings, retail tapes, bandages, cosmetics and all their raw materials. They have a customer base of 400, in 85 countries worldwide.
For their newest location in Katunsi, Bulgaria, we are looking for a:
QA/ QC Manager
About the role:
The QA/ QC Manager provides quality management, regulatory affairs, and Health and safety leadership across the
business within a highly regulated medical device environment. The successful candidate will be responsible for
management of the Quality Management System to the ISO 13485:2016 standard and all regulatory submissions to the
relevant authorities.
Job Responsibilities:
General Duties:
• Provide Quality & Regulatory strategic direction, training and support.
• Responsible for ensuring business activities are conducted in compliance with the regulations and standards applicable to our business and product range
• Plan and deliver the Regulatory registration/submission documentation required to achieve global and local market access.
• Ensure product lifecycle activities meet the Quality & Regulatory requirements of applicable global and local markets.
• Responsible for the planning and hosting of external Quality audits/inspections.
• Ensure Regulatory submissions and claims are fully supported by product documentation at all stages of the product lifecycle.
• Rather than developing the QMS themselves, the QA/ QC Manager acts as a project manager for the ISO certification ‘project’.
• Ongoing duties include reporting on how well the QMS is working and where it is not. The kinds of information to be reported will include things listed under Management Review (e.g. audit findings, customer feedback, suppliers, data establishing process trends = ‘KPI’s).
• The third duty is about making sure that the focus of the organization remains on the customer. This can mean but is not limited to training, induction for new hires, updating policies and sharing customer feedback.
Qualifications:
– Academic Level: University degree required; preferably in a technical discipline (Science or Engineering). Master degree preferred.
– Experience: 8 or more years’ experience in a manufacturing or quality environment.
– Has experience with a CE-compliant design control, change control, process control and quality system
management related to medical devices.
– Demonstrated computer skills (word processing, spreadsheets, graphics, and statistical tools).
– Experience in setting strategic direction while analyzing problems and improving products and processes.
– Experience in providing concise executive summaries of quality issues, changes needed or made, and results delivered.
– Ability to learn other computer-based systems as SAP.
If you are interested, please, send your CV with a recent photo.
Your personal information will be used only for the purpose of the recruitment process and will be treated with confidentiality and respect. Confidentiality is guaranteed and protected by law.
Horizons is a leading recruitment company specializing in expert and middle management positions with 18 years of experience in the Bulgarian market. Our team consists of business-oriented consultants with industrial specialization, a professional understanding of the business trends and a pro-active approach towards recruiting and hiring through different methodologies and innovations.
Horizons owns license No 2118 from 27.09.2016.