Olympus America Inc. Quality Engineer II in Littleton, Massachusetts
As a Title working on the Quality team, you will be empowered and inspired to do your best work. You will contribute to our mission by Adhering to the Quality standards established in the Quality Management System, Providing Quality support for the release of product and escalating quality issues identified while performing your daily duties. A typical day for you will include:
Reviewing Engineering change orders for completeness and accuracy testing product
Writing procedures and instructions
Creating test protocols
Supporting the Quality organization as needed
Working on a cross-functional teams providing quality input for new product development, procurement, manufacturing and servicing processes.
Researching changes to quality standards and regulatory requirements and reports impact to ISM business processes.
Assisting in the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and ISM quality policies and procedures.
Applying the requirements of the ISM Quality System by developing and driving measurable quality improvements relating to products, processes and services.
Developing solutions to manufacturing line quality issues.
Developing and documenting process and procedure development/changes.
Reviewing engineering change orders for compliance, accuracy and completeness.
Creating engineering change orders.
Applying appropriate analytical methods to evaluate current processes and process changes and develops new approaches to solve problems.
Creating validation and verification plans for new and existing products.
Executing acceptance tests and other test plans as needed.
Participating in the CAPA process as required as an assignee or project team member.
Reviewing customer complaints for completeness and accuracy and close in a timely manner.
Conducting internal and supplier audits and interfaces with suppliers to resolve Quality issues.
Bachelors's 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.
Background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003, and Canadian medical device requirements.
ASQ certifications in one or more of the following areas: 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.).
Ability to understand 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.
Proficiency 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.
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, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, 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.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus America Inc
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
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. We’re currently looking for a Quality Engineer II to join us in our Littleton, MA office.
Let’s inspire healthier lives, together.
The Quality Engineer II will provide Quality Engineering support to ensure compliance with the Quality System, regulatory requirements and the business strategy of the company. The incumbent represents Quality as a team member to support new product development, procurement, manufacturing, returns and servicing of products produced. He/She reviews and processes complaints.
Olympus America Inc at http://www.olympusamerica.com/
Quality Engineer II
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Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.