Coordinatelaboratory equipmentactivity to satisfy demands

Commissionequipmentand prepare and execute IQ, OQ and PQ activitiesasrequired

Develop and implement best practices for laboratory activitiesCreation and maintenance of Standard Operating Procedures, maintenance procedures and Health and Safety procedures.

Perform all necessary laboratory and ProductDevelopmenttesting and supply datarequiredfor FDA submissions Equipment will include metallographic, optical microscopy, chemical and physical analysis, dimensional measurement, First Article Inspection, etc., of metals, polymers, etc., as required.

Conduct DOEs, capability studies, MSAs, Technical report writing, Technical support, e.g. workmanship standards, product quality issue resolution, quality control support, engineering support, e.g. ECN generation.

Support3D-Printing prototyping. CAD file preparation, conversion to STL,3D-printer preparation and operation, post-processingand inspection

Work closely with the Quality Department to ensure all documentation associated with validation and new product introduction in a regulated environment isaccurate, executed in the correct sequence and completedin a timely manner

Participate in PFMEA, Control Plan, SOP, and PPAP generation for product transfers and launches.

Provide training for manufacturing team members.

Ensure adherence to GMP and safety procedures.

All other duties as assigned.

Holds a diploma/trade in a related discipline.

Has a minimum of 2years of experienceas a technician/in a technical role

Knowledge of and experience in metallographic preparationrequiredKnowledge of ASTM and ISO specifications

Strong computer literacy.

Experience with validation activities ina regulated industry

Demonstrated Mechanical/Technical Aptitude.

Strong communicationskills.

Ability to work on own initiative as part of a team in a fast-paced, results-oriented environment.

Proven problem-solving skills and hands-on approach.

Experience working in a regulated GMP-based machine-floor environmentrequired

Capable of working as part of a multi-disciplined team.

Ability to work to and meet timelines essential.

Attention to detail and accuracy when completing documentation isessential