Senior Quality Engineer

About the role

The Product Quality Engineer is responsible for the design, development and management of projects for legacy products. The role provides organizational support with a focus on Design Quality activities. They work with internal/external manufacturers providing finished products, services, components, and subassemblies to ensure compliance with company policies and procedures and medical device regulations.

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/Nerification 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.

Requirements

• 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 analyse, 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.
• Up to 10% domestic travel.

Qualifications

• Required: Bachelor's Degree in Engineering.
• 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 analyse, 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.
• Up to 10% domestic travel.

Skills

• Technical problem solving via Six Sigma type tools.
• Statistics, sampling strategies, and design of experiments.
• Risk Management practices, Corrective and Preventative Actions.
• Regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135, EUMDR and Human Factors.
• Written and oral communication skills.
• Fast-paced, dynamic and deadline-driven environment.
• Organized, flexible self-starter, team motivated and excellent at prioritizing and multi-tasking.
• Presentation development and public speaking.
• Domestic travel.

Benefits

• Competitive salaries.
• Annual bonus.
• 401(k) with company match.
• Comprehensive medical, dental, vision coverage effective on start date.
• 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.
• Paid volunteering and charitable donation/match programs.
• Employee Resource Groups.
• Dedicated Training Resources and Learning & Development Programs.
• Paid Educational Assistance.

Pay

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 to plan eligibility and other requirements).

Schedule

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

Location

Minnesota, Brooklyn Park

Company Information

Learn more about Life at Olympus: https://www.olympusamerica.com/careers

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.

Our headquarters is in Tokyo, Japan, and we employ 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.

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.

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.