Quality Engineer II, Product
Olympus Corporation of the AmericasAbout the role
Working Location: Minnesota, Brooklyn Park; Massachusetts, Westborough
Workplace Flexibility: Hybrid
For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus: https://www.olympusamerica.com/careers.
Job Description
The Product Quality Engineer is responsible for contributing to the design, development and management of projects for legacy products and support 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.
Job Duties
- Assist in the design and execution of Production Release Process projects for components and finished devices.
- Lead and implement complex projects, including quality improvement initiatives.
- Demonstrate project management skills while collaborating with cross-functional teams to achieve project objectives.
- Lead Process and Design Risk Analysis activities to identify, assess, and mitigate potential risks.
- Provide leadership and guidance regarding quality regulations and compliance requirements across functional disciplines.
- Support and lead Design Control activities for multiple new product development initiatives.
- Support Process Validation, Design Validation, Verification, and Software Validation activities to ensure product quality and regulatory compliance.
- Lead the implementation of cost of quality initiatives, including data collection, analysis, reporting, and continuous improvement efforts.
- Support Manufacturing Engineering in the creation and maintenance of Device Master Records (DMR), Device History Records (DHR), manufacturing routes, bills of materials (BOMs), print changes, and product specifications for both in-house and outsourced manufacturing.
- Ensure compliance with all applicable laws, regulations, policies, and procedures relevant to the role.
- Maintain the highest standards of professionalism, ethics, quality, and regulatory compliance in all work activities.
Job Qualifications
Required:
- Bachelor’s Degree in Engineering required.
- Minimum of 2-4 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
- Proficient with Six Sigma type tools to analyse, drive root cause, and solve problems.
- Knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
- Knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, & ISO 11135.
- Must be proficient and have practical knowledge in Microsoft Word, Excel, and PowerPoint.
- Must be able to work well within a team and independently at times with limited guidance.
- Strong written and oral communication skills are required.
- Ability to thrive in a fast-paced, dynamic and deadline-driven environment.
- Self-motivated with the ability to prioritize/execute multiple concurrent tasks.
- Skilled in presentation development and public speaking.
- General curiosity and a desire to learn new material.
- Up to 10% domestic travel.
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