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Career Opportunities: Senior Quality Engineer - Product (8192)

Remote: 
Full Remote
Contract: 
Full time
Experience: 
Senior (5-10 years)
Work from: 
United States

Offer summary

Qualifications:

Bachelor's Degree in Engineering, Minimum 5 years experience in FDA regulated medical device manufacturing.

Key responsabilities:

  • Lead design, development, and management of quality projects
  • Ensure compliance with regulations and company policies
  • Support cross-functional teams to drive compliant solutions
  • Lead product Design Control activities for new development
  • Create and support manufacturing documentation like DMR and DHR
Olympus Corporation of the Americas logo
Olympus Corporation of the Americas XLarge https://www.olympusamerica.com/
5001 - 10000 Employees
About Olympus Corporation of the Americas
At Olympus, we put a lot of good back into the world, and what we do, really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our purpose and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions. Olympus Corporation of the Americas (OCA)—a wholly owned subsidiary of Olympus Corporation in Tokyo, Japan—is headquartered in Center Valley, Pennsylvania, and employs more than 5,300 people at our locations throughout North and South America. Join us! True To You. True To Society. True To LIFE.
See more Olympus Corporation of the Americas offers

Job description

 

Working Location: MASSACHUSETTS, WESTBOROUGH 

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

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 sub­assemblies 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 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. 
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 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. 
  • Up to 10% domestic travel 

 

Preferred:

  • 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.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Competitive salaries, annual bonus and 401(k)* with company match
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 24/7 Employee Assistance Program
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • 12 Paid Holidays
  • Educational Assistance
  • Parental Leave and Adoption Assistance
  • Volunteering and charitable donation match programs
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

 

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

 $  $     

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

 

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.

 

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

 

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.

 

Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

 

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

 

Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Risk ManagementOnline CommunicationMinitabExperimental DesignRegulatory RequirementsCorrective And Preventive Action (CAPA)Sustaining EngineeringPresentation DesignHuman FactorsPostmarketing SurveillanceStatisticsFDA RegulationsISO 13485 StandardISO 14644ISO 14971 StandardSampling Design

Other Skills

  • Problem Solving
  • Dynamic Personality
  • Team Motivation
  • Multitasking
  • Non-Verbal Communication
  • Organizational Skills
  • Public Speaking
  • Prioritization
Are you interested?

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