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Resonetics · 10 hours ago

Quality Engineer II

San Diego, CA

Full-time

Hybrid

Mid, Senior Level

$81K/yr - $96K/yr

5+ years exp

Resonetics is a global leader in advanced engineering and micro manufacturing, particularly in the medical device industry. The Quality Engineer II will provide quality support, manage interfaces with customers and suppliers, and utilize quality engineering techniques to ensure compliance with industry standards and continuous improvement in manufacturing processes.

Life ScienceManufacturingMedical Device

No H1B

Responsibilities

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

Qualification

Quality EngineeringLean Six SigmaISO 13485 complianceStatistical softwareCQE certificationProcess ValidationTechnical writingCommunication skillsAttention to detailOrganizational skills

Required

Minimum 5 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

Experience with databases and Business Intelligence (PowerBi, Tableau, etc)