The Albert C. Wiltshire Employment Center recruits qualified candidates for positions within the Brooklyn Navy Yard, a 300-acre industrial park housing over 400+ businesses within the manufacturing, food, media, technology, and creative fields

A Brooklyn Navy Yard-based medical equipment manufacturer is seeking a Quality Assurance Manager to join the team.

Working Hours: 9:00 AM- 6:00 PM

Employee Status: Exempt

Responsibilities:

• Administer, maintain, and improve the Document and Record Control System within the company's Medical's Quality Management System.

• Design and compile Quality Documents, including but not limited to SOPs, Design Documents, and Work Instructions.

• Ensure original and electronic document confidentiality and security are maintained.

• Creation of Quality Records including but not limited to CAPAs, complaints, and Training files.

• Compile and report on Quality Metrics.

• Act as the management Representative for FDA and third-party audits

• Training of new employees on GMPs and Quality procedures, and ongoing training for current employees

• Ensure current procedures are implemented and can maintain consistency, compliance, and conformance across the organization.

• Provide quantitative KPI’s for the Quality Control team.

• Manage a Quality Control Team.

• Establish quality procedures, standards, and specifications for a company

• Collaborate with an organization’s purchasing manager to ensure raw materials from external suppliers meet quality requirements

• Carry out research to identify ways to reduce waste and maximize resources

• Conduct surveys to identify customer requirements and ensure they are being met by established quality standards

• Offer recommendations to company management on ways to improve on existing quality processes

• Collect, compile, and analyze relevant quality statistical data to obtain information regarding quality performance

• Supervise technicians, inspectors, and other company staff to ensure they perform their duties in line with established quality procedures

• Monitor product development processes to identify deviations from quality policies

• Work with QA manager to conduct tests to verify the quality of raw materials and finished products

• Review existing process and product specification to identify the need for improvement or upgrade

• Approve compliant products and reject defective ones

• Prepare and present reports to update upper management on quality activities

• Maintain proper records of quality test, procedures, and standards.

• Preparation of 510(k) submissions for new products

• Lead the Quality/Product Development Meeting with MDI, MCI, and MDL.

• Collaborate with other Department Leaders on specific business initiatives.

• Continual improvement of the Quality Control Department and accomplishing yearly departmental goals that coincide with Company’s goals

Job Type: Full-time

Pay: $36.06 per hour

People with a criminal record are encouraged to apply

Work Location: On the road

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