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Resonetics · 2 days ago

Quality Engineer II

Hutchinson, MN

Full-time

Onsite

Entry, Mid Level

$80K/yr - $90K/yr

2+ years exp

Resonetics is a global leader in advanced engineering and micro manufacturing within the medical device industry. The Quality Engineer II role involves applying advanced Quality Engineering techniques to support quality management systems, manage customer and supplier interfaces, and ensure compliance with industry regulations.

Life ScienceManufacturingMedical Device

No H1B

Responsibilities

Demonstrates strong proficiency in applying various tools and methods to identify and realize new product or process introductions (ex. QMS, product related), and business improvements

Leads and contributes to the application of various risk management and risk mitigation tools and practices

Leads and/or contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions

Conducts and supports the development of test methods in equipment, process, and product qualifications/validations

Develops, implements, and/or maintains process Quality control plans are in accordance with product risk level and are followed

Develops, implements and/or maintains process controls using appropriate techniques and tools (ex. Statistical process controls, statistical inspection sampling)

Supports all levels of Design Controls per ISO 13485:2016 and QSR 21 CFR 820

Participates in design/technical reviews as appropriate

Lead QE on product development projects

Interprets standard and non-standard sampling plans

May act as a subject matter expert (SME) in at least one routine Quality area

Liaising with customer quality personnel to resolve issues and Customer Complaints

Generating process deviations, Customer Change Notices, validation protocols & reports

Assisting with troubleshooting of production and product development processes

Leading development of metrology equipment

Developing and maintaining quality/control plans

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

Resolving Corrective and Preventive Actions

Developing Quality Procedures and conducting training to all personnel as appropriate

Approving Nonconformance disposition

Analyzing production and validation data

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

Qualification

Quality EngineeringISO 13485Lean Six SigmaStatistical softwareTechnical writingSelf-managementAttention to detailOrganizational skills

Required

Ability to create job-related documentation for quality purposes

Familiarity with ISO 13485 standards and 21 CFR 820 regulations

Minimum 2 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