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Sr. quality engineer

Gala Therapeutics

This is a Full-time position in Edison, NJ posted February 1, 2020.

Position Title Sr. Quality Engineer General Description The Sr.

Quality Engineer is responsible for evaluating design outputs for quality requirements and establish and/or maintain quality, risk, or other management plans for equipment and processes for general and specific product performance needs.

The Quality Engineer is accountable for supporting new product development and/or product sustaining activities through the application of Quality engineering skills for medical devices.

This person is also responsible for supporting the continued maintenance and growth of Gala’s Quality Management System Key Responsibilities
· Support the development and deployment of the quality system that meets company objectives.

· CAPA documentation.

· Document and evaluate non-conforming material issues.

· Supplier quality activities including audits, creation of supplier files, follow-up of audit findings, etc.

· Support documentation and completion of Verification and Validations activities including, traceability to requirements in compliance with applicable quality system regulations.

· Create and update verification and validation documentation.

· Responsible for DCN implementation activities
· Provide support as necessary in trending of quality metrics.

· Support engineering related activities including protocol development, executing protocols, and authoring test reports.

· Facilitate the documentation of risk management using industry standard tools including FMEAs, Fault Tree Analysis for systems, and other workflows to ISO 14971.

· Designs and specifies product inspection and process monitoring methods and criteria.

· Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and QMS improvement.

· Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
· Support design control activities include implementation of design and process changes.

· Support receiving inspection, inventory, purchasing and other activities as needed.

Key Requirements Education and Training: B.S.

in Engineering or equivalent.

Skills and Experience:
· 5+ years’ experience in medical device field, inclusive of 3+ years quality-related experience
· Prefer experience with capital equipment and with disposable products Position Reports To: Senior Manager, Quality Affairs