Senior Engineer - Design Quality Assurance

Olympus Corporation of the Americas•Westborough, MA

1d•Hybrid

About The Position

The Design Quality Assurance Engineer is responsible for the design, development and management of new products under development. The Product Quality Engineer provides organizational support with a focus on Design Quality activities. Works with internal/external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations. The Product Quality Engineer will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.

Requirements

Bachelor’s Degree in Engineering required.
Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
Up to 10% domestic travel.

Nice To Haves

Strong working knowledge of technical problem solving via Six Sigma type tools to analyze, drive 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, 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.

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.
Lead multiple product Design Control activities for new product development efforts.
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.