Senior Quality Engineer - NPD & Medical Device (Hybrid)

Olympus Corporation; Minneapolis (MN); Hybrid; USD 96,000 - 129,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

401(k) match

Medical, dental, vision coverage

Wellbeing programs

Paid vacation and sick leave

Parental leave

Holidays

On-site daycare / fitness center

Job summary

Olympus Corporation is seeking a Product Quality Engineer to lead design quality activities for New Product Development and ensure compliance with medical device regulations. You will collaborate with Operations, R&D, and Supply Chain to improve products and processes.

The role requires 5+ years in quality engineering in FDA-regulated environments, strong Six Sigma and statistics skills, and experience with Design Control and risk management.

Qualifications

• Bachelor’s Degree in Engineering required.
• Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
• Strong working knowledge of Six Sigma type tools to analyse, drive root cause, and solve problems.
• Proven track record in NPD Engineering, support of commercialized products and Post Market Surveillance.
• Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
• Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135, EUMDR and Human Factors.
• Strong written and oral communication skills.
• Ability to thrive in a fast-paced, dynamic and deadline-driven environment.
• Well organized, flexible self-starter, team motivated and excellent at prioritizing and multi-tasking.
• Skilled in presentation development and public speaking.
• Up to 10% domestic travel.

Responsibilities

• Drive the design & execution of Production Release Process project for components & finished devices.
• Lead and implement complex projects including quality improvement initiatives.
• Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Lead Process/Design Risk Analysis.
• Provide leadership in understanding of the quality regulations to other disciplines.
• Lead multiple product Design Control activities for new product development efforts.
• Support Process/Design Validation/Verification activities and approach including software validation.
• Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting.
• Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Skills

Six Sigma

NPD Engineering

Design Controls

Process Design

Regulatory Knowledge (FDA QSR, ISO 134

Education

Bachelor’s Degree in Engineering

Tools

Minitab

Job description

Olympus Corporation is seeking a Product Quality Engineer to lead design quality activities for New Product Development and ensure compliance with medical device regulations. You will collaborate with Operations, R&D, and Supply Chain to improve products and processes.

The role requires 5+ years in quality engineering in FDA-regulated environments, strong Six Sigma and statistics skills, and experience with Design Control and risk management.