Quality Assurance Manager
Our client is a class III medical device company specialised in improving clinical outcome of patients with impaired cardiac function. The company develops and will commercialize in 2018 devices aiming to improve outcomes for severe heart attack patients.
Our client’s offices are based between Louvain-la-Neuve and Brussels. The company is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please contact us via email@example.com.
Our client offers a culturally diverse English speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.
For the expansion of the team in Belgium, we are looking for an (m/f):
Quality Assurance Manager
As a Quality Assurance Manager, you are responsible for managing the QA team, product quality and release. You provide support in the Quality Management System implementation and maintenance. This includes the development of systems, policies/procedures and programs to ensure compliance with the FDA regulations, ISO standards, and other international requirements. You also support product development and manufacturing activities. Your main responsibilities are:
- Act as the Management Representative as prescribed in the Quality System Regulation 820, ISO 13485:2012, and EU Medical Device Directive (EU MDD 93/42/EEC).
- Ensure quality product is available to customer through product design, design review, engineering, customer/vendor relations, manufacturing quality, cost reduction, inspection, environmental monitoring, calibration, training, product sterilization, customer complaints and MDRs.
- Understand and assure conformance to regulations applicable to the department and interfaces with regulators during various inspections
- Develop and implement systems that monitor the Quality Management System (QMS) and report to management periodically on audit results, corrective action and performance. Recommend and drive improvements. Follow up and support of employees and teams to ensure corrective actions are initiated, implemented and measured for effectiveness.
- Develop and ensure that short and long range quality strategy, plans, goals, annual operating plans and budgets are aligned with the business.
- Write/Review engineering test protocols, reports, Risk Management tools including FMEA’s (Design Process), CTQ’s, Design Verification and Validation, Control Plans, DOE, MSA, and Process Validation plans. Participate in and manages quality assessments of internal operations and suppliers to analyze compliance and assess risk
- Perform supplier audits, internal audits and interacts with suppliers and customers to resolve non-conformances and drive continuous improvement
- Manage coaching, training, evaluations of subordinates from the department
- Engineering or Scientific Master degree, or equivalent through experience.
- Around 10 years experience in QA management positions (including commercial product release responsibilities) in the medical devices industry.
- Strong leadership, project management and communication skills together with hands-on and pragmatic mind-set.
- Strong understanding of FDA/ISO standards and industry expectations : voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing, etc.
- Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
- Very good organizational, analytical and problem solving skills.
- Ability to work in a fast-paced, highly integrated team environment where accuracy, accountability quality, safety and timeliness are essential.
- Highly collaborative, self-motivated and team-oriented individual in a company setting.
- Excellent oral and written communication skills in English. Any other language is a plus.
- A challenging and diversified position within a high-potential innovative medical device company.
- To work in a human size, dynamic, respectful and professional environment.
- International exposure, with learning and development opportunities.
- Varied contacts through external collaborations and partnerships.
- An attractive compensation package in line with the position responsibilities and your experience.
Please send your CV together with an adapted cover letter via www.pahrtners.be/job/quality-assurance-manager/ or to firstname.lastname@example.org. Ref: QAM. Your application and related information will remain strictly confidential.
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