Senior Engineer - Design Quality Assurance

Req ID: 4724

Working Location: MASSACHUSETTS, WESTBOROUGH

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.

Let’s inspire healthier lives, together.

Job Description

The Design Quality Assurance Engineer is responsible for the design, development and management 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

* 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.

*Lead multiple product Design Control activities for new product development efforts.

* 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/Verification 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 Requirements

REQUIRED QUALIFICATIONS:

* Bachelor’s Degree in Engineering required.

* Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.

* Up to 10% domestic travel.

PREFERRED QUALIFICATIONS:

* 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, 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.

#LI-LR1

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ 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 overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

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 ||

Nearest Major Market: Worcester
Job Segment: QA Engineer, Quality Engineer, QA, Quality Assurance, Medical Device Engineer, Engineering, Quality, Technology

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