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Quality Engineer II

Req ID:  2188

Working Location: MASSACHUSETTS, LITTLETON 

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 Quality Engineer II provides Quality Engineering support to ensure compliance with the Quality System regulatory requirements and the business strategy of the company. They represent Quality as a team member to support new product development procurement manufacturing returns and servicing of products produced. They review and process complaints.

Job Duties

* Quality department representative on cross-functional teams providing quality input for new product development procurement manufacturing and servicing processes.

 

* Researches changes to quality standards and regulatory requirements and reports impact to ISM business processes.

 

* Assist in the implementation compliance and maintenance of standards (e.g. FDA ISO13485) and ISM quality policies and procedures.

 

* Applies the requirements of the ISM Quality System by developing and driving measurable quality improvements relating to products processes and services.

 

* Develops solutions to manufacturing line quality issues. Develop and document process and procedure development/changes.

 

* Reviews engineering change orders for compliance accuracy and completeness.

 

* Creates engineering change orders.

 

* Applies appropriate analytical methods to evaluate current processes and process changes and develops new approaches to solve problems.

 

* Creates validation and verification plans for new and existing products.

 

* Executes acceptance tests and other test plans as needed.

 

* Participates in the CAPA process as required as an assignee or project team member.

 

 * Review customer complaints for completeness and accuracy and close in a timely manner.

 

* Conducts internal and supplier audits and interfaces with suppliers to resolve Quality issues.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelors degree in engineering discipline or equivalent.

 

* Minimum of  3 years related experience and/or training; preferably in the medical device industry related to process/quality engineering.

 

* Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD 93/42 ISO 13485-2016 and Canadian medical device requirements.

 

PREFERRED QUALIFICATIONS:

 

* ASQ certifications in one or more of the following areas is preferred but not required: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).

 

* Good statistical and analytical skills.

 

* Working knowledge of problem solving tools (i.e. process mapping histograms FMEA risk assessment cause & effect diagrams PDCA Pareto analysis etc.)

 

* Understands design controls and Engineering change order process Quality costs and assessment statistical methods technical writing metrology & calibration inspection and testing sampling principles and AQL TQM Lean Six Sigma etc.)

 

* Good verbal and written communication skills demonstrated by ability to generate technical reports and presentations for management.

 

* Proven project management skills.

 

* Proficient in the use of information technology and applications.

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 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) || Littleton || 


Nearest Major Market: Boston

Job Segment: Quality Engineer, Manufacturing Engineer, Engineer, CAPA, Engineering, Quality, Management

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