Quality Engineer II, Product

Olympus Corporation of the Americas; Westborough (MA); Hybrid; USD 83,000 - 112,000; Full time

Benefits offered by this job

Competitive salary

401(k) with company match

Wellbeing programs

Paid vacation

Parental leave

On-site amenities

Job summary

Olympus Corporation of the Americas is seeking a Product Quality Engineer to contribute to design, development and management of projects for legacy and new medical devices. You will partner with Operations, R&D and Supply Chain to continuously improve products and processes and ensure regulatory compliance.

The role requires 2–4 years in quality engineering within FDA-regulated medical devices, expertise in Six Sigma and risk analysis, and strong collaboration across teams.

Qualifications

• Bachelor's degree in engineering is required.
• 2–4 years of quality engineering experience in FDA-regulated medical devices.
• Proficient with Six Sigma tools and root-cause analysis.
• Knowledge of statistics, sampling, and DOE; familiarity with Minitab.
• Strong regulatory understanding (FDA QSR, ISO 13485, ISO 14971, ISO 11135).
• Proficient with Microsoft Word, Excel and PowerPoint.

Responsibilities

• Lead and implement complex quality projects across design and production.
• Drive design and process risk analyses to identify and mitigate risks.
• Provide guidance on regulatory compliance and quality regulations.
• Support Design Control activities for new product development.
• Support process validation, design validation, verification, and software validation.

Skills

Six Sigma

Statistics

Regulatory compliance

Microsoft Office

Team collaboration

Education

Bachelor’s Degree in Engineering

Tools

Minitab

Job description

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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 ofpatient 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.

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.

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Benefits

• Equitable Offerings you can count on:
• Competitive salaries, annual bonus and 401(k)* with company match
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full-time position in this location is$82,862.00-$111,864.00/ year, plus potential for annual bonus(subject toplan eligibility andother requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||Quality & Regulatory Affairs (QA/RA)