Quality Engineer - North Haven, United States - Katalyst Healthcares and Life Sciences

Katalyst Healthcares and Life Sciences North Haven, United States

5 days ago

Description

Responsibilities:
Establish and maintain master validation program, including site and individual products and process master validations. Create/Review/Support validation protocols and reports to support process and reliability improvements. Support complaint handling program, including complaint analysis, investigation, and follow up.

Lead and/or support reliability and process improvements projects from quality perspective Establish and maintain process controls/SPC for specific production processes.

Support corrective and preventive action (CAPA) program Review and modify product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements.

Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life, reliability, and electrical safety. Review and provide feedback of protocols and reports, test vendor qualification, and testing management. ssist with the development and maintenance of product risk management files. ssist with design verification testing and test method assessment and validation activities.

Recommend requirements for first article inspection, incoming and in-process inspections, and lot release testing, including sampling strategy and test methods.

Participate in failure investigations to analyse internal system or process failures and to implement corrective and preventive action. Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriate quality controls are implemented. udit Design History Files and works with cross functional team to resolve documentation issues. Identify and implement good quality engineering practices, including statistical methods and root cause analysis tools.

Participate in supplier material related processes which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products.

Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective, and remediation action plans, and for corrective and preventive actions.

Demonstrate the ability to implement ISO 14971, including risk evaluation techniques.

Requirements:
Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university 5+ years related experience and/or training; or equivalent combination of education and experience

Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military, nuclear. working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, ISO10993,ISO 11135, and the EU Medical Device Directive is a plus. Familiarity with test methods and standards for the design, verification, and validation of medical device products is required. Experience with PPAP, PMEA

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