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Quality Engineering Project Manager

Mansfield, MA

Industry: Healthcare/Med./Biotech/Pharma Job Number: 48238 Pay Rate: $80 - $90k
The Quality Engineering Project Manager is responsible for implementing, supporting, and sustaining elements of the quality system through procedure generation, training, auditing, and technical support.

The quality engineering project manager manages new product development, continuous improvement projects, and/ or production support; or manages the RMA operation.

Plan to spend 1-2 years in this initial position with the ability to move into organizations across the globe beyond this role. You will be exposed to a broad range of projects available such as New Product Development, Manufacturing, Facility Expansion, Acquisitions, Regulatory Compliance, and so on.

Promotion fast track for high performers with yearly merit increases.

Position functions:

- Support sustaining engineering and continuous improvement via project quality plans, which may include needed inspection, test, and audit procedures; assist with identification of needed reliability testing, storage stability testing, biological testing, sterilization adoptions; identification and procurement of needed gauges, equipment, and so on; and support of process/product validation.

- Ensure compliance to electrical safety standards along with any product specific safety standards and perform bench-top testing on electrical generators per the requirements of the standards if managing Controller Quality Engineering function.

- Generate/approve validation studies, capability studies, Failure Mode Effects Analysis/Hazard analysis, and collaborate with engineering, manufacturing, and regulatory, and work with outside labs and suppliers if managing new product development QE function.

- Support manufacturing operations in the US and globally if supporting and managing sustaining QE function.

- Ensure that compliance to cGMP, EN/ISO 13485/MDD, and ISO 14971 requirements are maintained.
- Support FDA and other compliance related audits.
- Ensure compliance with quality system and all relevant internal procedures and policies.

- Develop and work with area teams to implement continuous quality improvement programs which may include: vendor certification for ship to stock; design of experiments to identify and thus control process variables; elimination of lot inspection.

- Initiation of process audit activities; and installation of statistical and non-statistical process controls.

- Lead the review of standard and non-standard analysis evaluation of issues such as the internal audit program, Corrective Actions and Preventive Actions (CAPA), materials review and complaint analysis.

- Assist area teams to maintain applicable regulatory compliance which may include new hire orientation training, internal and external Quality System Regulations and CAPA.

- Develop and administer an inspection, test, and/or audit program to assure that incoming, in-process, and finished product meets functional specifications and quality standards.

- Lead the review, disposition, and corrective action activities associated with discrepant components, materials, sub-assemblies and finished products.

$80 - $85k base, 10% bonus potential.

Engineering Degree, Leadership
Promotional potential, lots of growth nationally, multiple locations, high tech, history of hiring and promoting military talent for many years.
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