Quality Engineer II - Medical Devices (Onsite MN)

Olympus Corporation; Minneapolis (MN); On-site; USD 79,000 - 107,000; Full time

Benefits offered by this job

Competitive salaries and annual bonus

401(k) with company match

Comprehensive medical/dental/vision

Employee Assistance Program

Paid vacation and sick time

Parental leave and adoption assistance

12 paid holidays

On-site facilities

Job summary

Olympus Corporation in Minnesota (Brooklyn Park) is seeking a Quality Engineer to support the Quality System, regulatory requirements, and business strategy. You will be a key team member for new product development, transfers, manufacturing support, and service of products.

You will promote quality awareness, lead process improvements, apply statistics to improve processes, and assist with validation, CAPA, and audits.

Qualifications

• Bachelor's degree in science/engineering; equivalent industry experience.
• Minimum 3 years related experience, preferably in the medical device industry.
• Knowledge of basic mechanical testing and material properties.
• Knowledge of metrology.
• Familiarity with U.S. FDA QSR requirements including ISO 9001, MDD93/42, ISO 13485-2016, and Canadian Medical Device requirements.
• Good statistical and analytical skills.
• Working knowledge of Problem Solving Tools: Process Mapping, PDCA, FMEA, etc.
• Working knowledge of Quality Tools: Basic Statistics, Technical Writing, Metrology & Calibration, Inspection and Testing, etc.
• Strong verbal and written communication in cross-functional teams.
• Proficiency with IT applications.

Responsibilities

• Serve as a cross-functional member to support new product development and manufacturing transfers.
• Complete assigned Quality Engineering tasks to schedule.
• Promote awareness of Quality and Regulatory requirements.
• Lead or participate in process and procedure development/changes.
• Apply statistical methods to evaluate processes and changes.
• Support CAPA process and root-cause investigations.
• Assist in implementation of standards (FDA QSR, ISO 13485) and QA policies.
• Train site personnel on Quality System and regulatory standards.
• Provide support to metrology and inspection methods; support validation strategies.
• Develop and maintain Product Master Validation Plans.
• Collaborate on quality improvements and drive measurable results.
• Interface with SQE to resolve issues and support audits.

Skills

Quality Engineering

Statistical methods

Metrology

Quality Tools

Regulatory knowledge

Problem solving

Technical writing

Auditing

Education

Bachelor's degree in science/engineering

Tools

FDA QSR familiarity

ISO 13485

Job description

Olympus Corporation in Minnesota (Brooklyn Park) is seeking a Quality Engineer to support the Quality System, regulatory requirements, and business strategy. You will be a key team member for new product development, transfers, manufacturing support, and service of products.

You will promote quality awareness, lead process improvements, apply statistics to improve processes, and assist with validation, CAPA, and audits.