Senior Product Quality Engineer

Olympus Corporation of the Americas; Brooklyn Park (MN); Hybrid; USD 96,000 - 129,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Wellbeing programs

Paid time off

Parental leave

On-site daycare

Fitness center

Job summary

Olympus Corporation of the Americas is seeking a Product Quality Engineer in Minnesota with hybrid work options to lead design quality activities and ensure compliance with medical device regulations.

You will coordinate with Operations, R&D, and Supply Chain to improve products, manage design controls, and drive production release processes across components and finished devices.

Qualifications

• Bachelor's degree in Engineering is required.
• Minimum 5 years of experience in Quality Engineering within FDA-regulated medical device manufacturing.
• Strong problem solving using Six Sigma tools to analyze root cause and resolve issues.
• Experience with Sustaining Engineering and post-market surveillance.
• Familiarity with FDA QSR, ISO 13485, ISO 14971, ISO 11135, EU MDR and Human Factors.

Responsibilities

• Drive the design and execution of Production Release Process for components and finished devices.
• Lead complex quality improvement projects and cross-functional teams.
• Set direction for cross-functional teams toward compliant and efficient solutions.
• Lead Design Controls activities for new product development and validation efforts.
• Support manufacturing in creation of DMR, DHR, routes and BOMs.

Skills

Six Sigma

Root cause analysis

Quality engineering

Design Controls

Regulatory knowledge

Communication skills

Troubleshooting

Travel readiness

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 the design, development and management of projects for legacy products. 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

• 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 ValidationNerification 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.

Job Qualifications

Required:

• 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 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, 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.

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

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$95,904.00-$129,470.00/ 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) || Minnesota (US-MN) || Brooklyn Park ||Quality & Regulatory Affairs (QA/RA)