Quality Engineer

Overview

The Quality Engineer provides customer- and factory-facing quality support for contract manufacturing and development of medical device components and finished devices.  This position will focus primarily on improving quality systems infrastructure in a contract manufacturing environment. There will be a concentration on customer-related and internal process-related activities including surveys and audits.

 

The position includes:

• Managing the interface between Resonetics and customers’ supplier quality organization, assisting with transition and sustaining of laser micromanufacturing processes, and support for supplier quality management.
• Lead Quality activities during Design and Development Services: Serve as a key member of product development teams to perform activities related to design, development, process development and manufacture, and release of medical devices, including, but not limited to, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities.

 

The Quality Engineer position uses Quality Engineering techniques including Problem solving, root cause analysis, Lean Six Sigma methodologies such as PDCA, DMAIC, Process Validations, Process Development and optimization, Gage R&R, and DOE to reduce or improve inspection plans and support the sustaining of regulatory Quality Management Systems such as ISO 13485 and/or 21CFR820 compliance.

Compensation- $75,000- $90,000

Responsibilities

• Liaising with customer quality personnel to resolve issues and Customer Complaints and take ownership of the Customer Complaint reductions that affect the manufacturing and/or Design and Development Services.
• Partner with appropriate parties to resolve corrective and preventative actions (CAPA).
• Assist with customer and regulatory audits.
• Take ownership of assigned production readiness activities to ensure that quality awareness is inherent in process development.

• Monitoring and disseminating customer quality alerts and process deviations as required.
• Generating process deviations, Customer Change Notices, validation protocols & reports.
• Lead troubleshooting Quality opportunities during product launches and assisting with the Product Development Process.
• Leading development of metrology equipment
• Developing and maintaining quality/control plans and PFMEA.
• Ensuring Quality Management Systems procedures and appropriate regulations and industry standards are being utilized throughout the product development and process development processes. 
• Developing Risk documentation in compliance with the QMS and regulatory standards, such as PFMECAs.
• Conducting Gage R&R studies and Design of Experiments
• Developing Quality Procedures and conducting training to all personnel as appropriate
• Approving Nonconformance disposition
• Analyzing production and validation data with advance statistic such as:
• Anova & Regresion
• CPK, PPK & CP
• Control Charts
• SPC
• Gage R&R
• Design of Experiments
• Working on continual improvement and process assessment projects as assigned
• Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.
• As a lead Quality Engineer on development projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for product builds.
• Support Equipment Calibration and Maintenance per the applicable procedures.

Qualifications

• Minimum 3 years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience
• Demonstrated technical writing and communication skills.
• Working knowledge of Statistical software and/or Minitab
• Bachelor’s degree or equivalent experience
• Interact with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.