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Quality Engineering Project Manager
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.
- 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.