Design Assurance Lab Supervisor

Job Description

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Job Description

The R&D DA Lab Supervisor will be a part of the R&D quality organization and lead the Design Assurance (DA) Lab . The individual will be responsible to set up, control and maintain the design assurance lab and supervise the activities of personnel in the design assurance lab area. Ensure that daily testing schedules are met, and that testing standards and procedures are followed. Establish and support a work environment of continuous improvement that supports the appropriate regulations for testing.

The individual will also be responsible for assuring all requirements for the Product Development Process (PDP) design verification and validation are met by: a.) Providing quality and compliance input to the project team for project decisions and deliverables (e.g. Master Verification and Validation Plan, Test Methods, Design Verification and Validation, Usability Testing) whether internal, co - developed or externally manufactured, b.) Providing quality and compliance input and coaching for Product Verification and Validation, and c.) Supporting corporate quality initiatives utilizing their PDP, Design Control, and Verification and Validation expertise.

The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures and should be comfortable working in a matrix organizational structure.

Key Responsibilties/Deliverables

• Lead the R&D design assurance lab set up, control and management activities.
• Lead the development and implementation of lab equipment installation, qualification plans (IQ, OQ and PQ qualification) and ensure calibration and preventive maintenance of lab equipment are performed per the prescribed due dates.
• Preparing equipment s work instructions / SOP s and monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
• Following and ensuring strict safety procedures and safety checks and assist in the development of new training methods and updating current training to be more understandable for technicians and other lab personnel.
• Identifies and implements effective systems and testing controls supporting the development, qualification, measurement, or ongoing testing of products.
• Support the development and implementation of fixture design, qualification and test method validation.
• Execution of product testing in DA lab as per the laid down SOP/WI, Protocols.
  • Planning of tests in case of multiple projects running simultaneously.
  • Preparing specimens and samples.
  • Preparing the test equipment setup.
  • Understanding of the SOP/WI, test Protocols/Reports.
• Record, interpret, analyze & compile data
• Assist project teams in establishing specifications and quality standards
• Operate and maintain test equipment as per the requirements.

Academic Qualifications & Experience

• Bachelor s in engineering with preference mechanical engineering, plastics and polymer engineering and reliability.
• 10+ years engineering experience and at least 5 years of experience in medical device R&D engineering.
• Past experience of managing medical device lab will be an added advantage.
• Professional training and certification in Quality Management Systems including ISO 13485, Testing and Calibration ISO17025, Risk management ISO 14971, design assurance / control and CAPA/NCEP management.
• Experience working in a highly regulated environment and sound understanding of medical device regulatory requirements for Class II and III medical devices.
• Well versed with statistical analytical techniques and s/w tools like MINITAB.
• Preference for candidates with PMP certification or similar project management training and experience resourcing, timelines, quality and budgets.

Keyskills :
designassurance workinstructions projectmanagement qualitymanagement classii iso13485 fixturedesign riskmanagement iso14971 designcontrol testequipment projectmanagementtraining projectteams qualitystandards medicaldevices producttesting