Senior Quality Engineer

1 week ago

Watertown, United States Exergen Corp Full time

Exergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously possible.

Our Temporal Scanner is the most efficacious, non-invasive thermometer ever created. Exergen holds over 100 issued and pending U.S. and foreign patents, and is the only manufacturer of retail medical thermometers in the U.S. Presently, half of hospitals and pediatricians currently use the Exergen Temporal Scanner, and well over 14 million consumers use one at home.

Founded by Harvard-research scientist, Dr. Francesco Pompei, over three decades ago, Exergen Corporation is based in Watertown, Massachusetts, USA.

Senior Quality Engineer

Reports to VP of Quality Assurance and Regulatory Affairs.

Duties and Responsibilities

Lead the Incoming Inspection team and associated processes. Run the Material Review Board (MRB) meetings, identify compliance gaps, conduct root cause analysis and corrective actions for non-conforming components.

- Work with suppliers and Companys internal manufacturing to implement sustaining and cost reduction activities.

- Participate in the companys Internal Audits program to ensure that compliance and regulations are followed.

- Support external audits: MDSAP, MDD/MDR, In-Metro, suppliers, etc.

- Provide support to the manufacturing engineering team in troubleshooting, implementing improvements, training on new products or processes, verify documentation compliance.

- Support development, validations, documentation and release of the manufacturing and testing processes to support new product implementation or existing products. Ensure that product quality meets applicable WW requirements and documentation is complete prior to an ECO initiation.

- Analyze companys process data to identify opportunity for improvement of the product reliability or efficiency in operations and/or to reduce cost. Lead CAPA meetings.

- Review and maintain Manufacturing Procedures (MPs), Test Procedures (TPs), Calibration Procedures (CPs), and Quality Control Instructions (QCIs).

- Lead Complaint Committing meetings. Provides input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.

- Support the Engineering team with new product development and risk management activities. .

- Support Regulatory and Engineering team with verification and validation of the new product line, processes, software, materials, or vendors, as required, and document the results in Technical Documents (TD).

- Review equipment validation plans (IQ/OQ/PQ). Ensure compliance with current regulatory requirements prior to the ECO processing.

- Initiate and process Engineering Change Orders (ECO) and Temporary Change Orders (TCO) per established procedure.

- Adhere to established procedures under Exergens Quality System. Assure that the processes are followed by each department. Conduct internal audits with the internal team.

- Prove continuous product and process improvement and proactively identify and implement best-in-class quality engineering practices.

- BS in Engineering (Biomedical, Mechanical, Industrial, Operations).

- 7+ years of experience in medical device manufacturing or regulated industries.

- Experience working in high-volume manufacturing industry.

- Proficient with dimensional inspection and test equipment.

- Lean manufacturing approach and internal auditing experience a plus.

- Working experience in medical device industry with knowledge of FDAs guidance documents

and regulations,

ISO and WW standards.

- Thorough understanding of industry regulations: GMP, ISO QMS standards (21CFR820, ISO13485, EN ISO 60601 and others).

- Excellent organizational, record keeping, and communication skills (verbal and written) and ability to effectively interact with staff and management.

Qualifications

- BS in Engineering (Biomedical, Mechanical, Industrial, Operations).

- 7+ years of experience in medical device manufacturing or regulated industries.

- Experience working in high-volume manufacturing industry.

- Proficient with dimensional inspection and test equipment.

- Lean manufacturing approach and internal auditing experience a plus.

- Working experience in medical device industry with knowledge of FDAs guidance documents

and regulations,

- ISO and WW standards.

- Thorough understanding of industry regulations: GMP, ISO QMS standards (21CFR820, ISO13485, EN ISO 60601 and others).

- Excellent organizational, record keeping, and communication skills (verbal and written) and ability to effectively interact with staff and management.

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