Onsite Quality Engineer II – Medical Devices

Olympus Corporation

Minneapolis (MN)

On-site

USD 79,000 - 107,000

Full time

7 days ago

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Benefits offered by this job

Competitive salaries

401(k) with company match

Comprehensive medical, dental, vision

Paid Vacation and Sick Time

Parental Leave and Adoption Support

Holidays and onsite amenities

Job summary

Olympus Corporation is seeking a Quality Engineer to provide Quality Engineering support to ensure compliance with the Quality System, regulatory requirements and the business strategy of the company. You will represent Quality in a cross-functional team supporting new product development, transfers, manufacturing, procurement, returns and servicing of products.

You will apply statistical methods to evaluate processes, lead process improvements, train site personnel on quality standards, and

Qualifications

Bachelor's degree in science/engineering.
Equivalent industry experience.
Minimum of 3 years related experience preferably in the medical device industry related to process/quality engineering.
Knowledge of basic mechanical testing and material properties.
Knowledge of metrology.
Requires background and 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, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.
Working knowledge of Quality Tools: Quality Planning, Quality Costs and Assessment, Basic Statistics, Advance Statistical Techniques, Technical Writing, Metrology & Calibration, Inspection and Testing, Sampling Principles and AQL, TQM, Lean Six Sigma, etc.
Strong verbal and written communication skills in a cross-functional team environment.
Demonstrated ability to generate technical reports and the ability to make presentations to middle and upper management.
Proficient in the use of Information Technology and applications.

Responsibilities

Support new product development, transfers, procurement, manufacturing, and servicing from a Quality Engineering perspective.
Complete assigned Quality Engineering tasks to schedule.
Promote awareness of Quality and Regulatory requirements.
Lead or participate in the development of process and procedure development/changes.
Apply statistical methodology to evaluate current processes and process changes.
Develop new approaches to solve problems identified as part of the team.
Assist in the implementation, compliance and maintenance of standards (e.g., FDA QSR ISO 13485) and QMS policies and procedures.
Train location personnel on all aspects of the Quality System and regulatory standards.
Apply the requirements of the Quality System to processes, products or services for the location.
Support the manufacturing line to address quality issues and resolution.
Provide support to metrology, component inspection methods and preventive maintenance programs.
Support validation and verification strategy for new and existing products and processes as assigned.
Lead the development and maintenance of product Master Validation Plans.
Participate in the CAPA process as required as a CAPA Lead or CAPA project team member.
Investigate escalated product complaints related to manufacturing issues to root cause and ensure timely customer response and correction.
Monitor product and process performance metrics and act upon trends; lead MRB as needed.
Author, collaborate on and approve Quality System documentation including changes orders, DHF, DMR, DHR, labels and labelling.
Support site regulatory inspections, internal audits or customer audits as requested; interface with SQE to resolve issues.
Develop and drive measurable quality improvements relating to products, processes and services.
All other essential duties as assigned.