Senior Quality Engineer - Hybrid Medical Devices

Olympus America, Inc.; Westborough (MA); Hybrid; USD 96,000 - 129,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

401(k) with company match

Employee Assistance Program

Wellbeing programs

Paid vacation and sick time

Parental leave

Job summary

Olympus America, Inc. in Westborough, MA is seeking a Product Quality Engineer to design, develop and manage quality projects for legacy devices.

You will partner with Operations, R&D, Supply Chain to improve products and processes while ensuring compliance with FDA QSRs and ISO standards; this role is hybrid and located in Massachusetts. Responsibilities include leading production release design, risk analysis, Design Control activities, and supporting manufacturing engineering with DMR/DHR and

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 tools to analyze root cause and solve problems.
• Proven track record in Sustaining 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, EU MDR, 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 and 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 tools

Root cause analysis

Cross-functional collaboration

Quality systems

Regulatory knowledge

Statistical software

Education

Engineering degree

Tools

Minitab

Job description

Olympus America, Inc. in Westborough, MA is seeking a Product Quality Engineer to design, develop and manage quality projects for legacy devices.

You will partner with Operations, R&D, Supply Chain to improve products and processes while ensuring compliance with FDA QSRs and ISO standards; this role is hybrid and located in Massachusetts. Responsibilities include leading production release design, risk analysis, Design Control activities, and supporting manufacturing engineering with DMR/DHR and