La société Profile Group is a premium Selection and Recruitment company that has been helping candidates in their job search for 30 years.
Working with a wide variety of companies, we provide candidates with a high quality service that helps both in the application process and improving the various skills required to succeed in interviews.
Our client, Physiol, a member of the BVI group specialized in ophthalmic surgery, is involved in the research, development and manufacture of intraocular implants for cataract surgery.
Function As a QC Manager, you have the following responsibilities : Post Market Surveillance You work closely with RA / QA, R&D, Industrialisation, Operations, Clinical and other functional areas to evaluate actual of potential product failures and update risk management files as needed You support QA in the Complaint management process and you are responsible for managing a team in charge of investigating, determining root cause and ultimate resolution of product failures You contribute to product safety, product quality and customer satisfaction related decisions You participate and support internal and external supplier audits and inspections You monitor and advise on how the product quality is performing and publishes data and reports regarding the effectiveness of the quality management system Product Acceptance & Investigations You plan and conduct the analysis, inspection, design, tests and / or integration of test methods to assure the quality of assigned products or components You develop test methods and participate in the assessment of returned products, incoming, in-process and final test / inspection.
You apply statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes You coordinate the documentation review, inspection workflow, training, problem solving and calibration for test equipment You advise on changes and their implementation and provides training, tools and techniques to enable others to achieve quality You utilize statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities and develop statistically sound tolerance limits You participate in the non-conformance reporting system.
You identify non-conformance trends and develop and administer technical investigation and corrective action programs. Product Development & Operations You collaborate with R&D in the development and implementation of product test plans including Verification and Validation of products and processes You serve as liaison to design, procurement and manufacturing engineering You participate and / or lead validation programs of processes and product You perform standard quality engineering reviews of design documentation for compliance with stated requirements, including supplier quality and company quality records You work with Manufacturing Engineering to address supplier quality issues Tags : quality, quality assurance manager, quality control, QHSE manager, quality engineer, quality supervisor, quality control manager, QC, quality & compliance engineer, medical devices, assurance qualité, controle qualité, ingénieur qualité, biotech, pharma Profile Required education and experience : You have a master's degree in science or another technical field You have a minimum of 8 years’ experience with a first experience as a team leader in the medical device, Pharma industry or any other compliant environment.
You have knowledge in Medical device Quality system, including 21 CFR Part 820 (QSR) & ISO 13485 You demonstrate skills in statistical analysis You have experience in internal and external audit You have experience with CAPA, complaint investigation, field action processes and risk management You have strong computer skills General and behavioural skills and competencies : You have team leadership spirit You are recognized as a technical leader in the company You are able to lead a Continuous improvement Team, CAPA team, or working with a customer or supplier to resolve product quality issues You are assertive and unifying, you have a sense of dialogue and compromise You are self-sufficient Offer You join a dynamic and state-of-the-art environment in a company that encourages its teams to take initiatives and bring ideas that contribute to the success of the company.
Physiol offers you a position of responsibility, with a competitive salary package.