Manager, Advanced Quality Engineering - (US-MA-Attleboro - 02703)

Minimum Education: None
Jobcode: L:98490781
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Overview :


The candidate shall lead a team of Quality Engineers in the development of New Products. Candidate shall participate in franchise team meetings and work with functional managers towards the development of project schedules ensuring the inclusion of all regulatory and quality requirements. The Quality Manager will ensure the effective implementation of design controls in support of the development of new products. This candidate shall have proven leadership skills, and demonstrated ability in risk based decision making and problem solving. This position reports to the Director of Quality and is responsible for assuring that new product designs and processes meet all Corporate and Divisional requirements with respect to safety and efficacy. A general working knowledge of other quality systems elements such as CAPA, complaints handling, internal audits, process verification and validation, supplier controls, control of measurement and test equipment is expected.


Responsibilities :


•Lead a team of advanced quality engineers in design control activities for new product development projects. •Knowledge of combination products utilizing absorbable polymers and active pharma ingredients is a plus. •Perform product and process risk assessment activities, including Hazards Analysis, and Design/Process Failure Modes & Effects Analysis (DFMEA/PFMEA). •Ensure the execution of robust design validation and process validation activities. •Provide Quality Engineering leadership for analytical test methods and stability testing in order to ensure compliance with ICH guidelines, 21CFR 820, 210, 211, cGMP’s, and ISO-13485, requirements. •Oversee the development of biocompatibility test plans in compliance with ISO-10993 and Corporate guidelines. Co-ordinate the testing at outside laboratories. •Oversee the development of test methods used to characterize and assess the safety and efficacy of drug loaded medical devices. •Oversee the development of shelf life and stability test protocols for combination devices with Active Pharmaceutical Ingredients (API’s) and the development of test protocols and reports to support Regulatory submissions. •Support Corrective and Preventive Action Process for product/process non-conformances, customer complaints, and internal audits. •Support Product/Process Transfers from Pilot facilities to Manufacturing Facilities. •Special Projects as assigned.


Qualifications :


•Bachelor’s Degree (Master’s preferred) in Engineering or Technical Sciences. •A high level of competence in Quality Technology including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability etc. •General working knowledge and experience in FDA’s quality system regulations •3-5 years leadership experience in the medical device industry including product/process validation and technical problem solving. •A strong understanding of Analytical Test Methods, Stability Testing and Biocompatibility testing as applicable to combination products. •Strong oral and written communication skills. •Knowledge of ICH guidelines, FDA QSR’s, ISO13485:2003, and ISO 9001:2000. •Knowledge and Application of Six Sigma/Process Excellence Tools. Green Belt/Black Belt Certification a plus. Some travel required.