Olympus America Inc. RA Manufacturing Engineer in Bartlett, Tennessee
As an RA Manufacturing Engineer working on the Market Quality team, you will be empowered and inspired to do your best work. You will contribute to our mission by assisting in the complaint investigation, communicate and follow-up on event of description and work closely with manufacturing departments and customers to promote quality improvements. In a typical day, you will work on complaint investigation via investigation of the products, communicate with the manufacturing departments e.i. Quality Assurance, Manufacturing, Design Assurance, and R&D and document and close of complaints.
Liaise with manufacturing departments such as Engineering, R&D and QA to perform complaint and product quality investigations.
Perform hands-on investigations on complaints and products returned to the manufacturing site.
Perform Device History Record and Device Master Record reviews in response to complaint and product quality investigations.
Attend CAPA and NCR meetings to represent RA/QA.
Participate in corrective and preventative action activities.
Communicate with customers in support of complaint investigations, including but not limited to phone calls, letters, e-mails and site visits.
Perform trending on complaints and product quality issues associated with devices manufactured at the specific OSTA site.
Perform complaint handling related duties, including but not limited to, complaint creation, evaluation, investigation and closure.
Perform all other duties as required.
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 an RA Manufacturing Engineer to join us in our Bartlett, TN office.
Let’s inspire healthier lives, together.
The Manufacturing Complaint Engineer is responsible for assisting in the investigation of complaints and reportable events at several levels, with special emphasis on complaints requiring in-depth evaluations. This position requires a thorough understanding of FDA regulatory requirement for complaint handling and adverse event reporting. The incumbent must be able to communicate and follow-up on event description detail with internal and external customers in order to evaluate and investigate complaints. He/She will work closely with manufacturing departments and customers to promote quality improvements to both products and quality system processes by initiating and driving corrective and preventive actions. The Manufacturing Complaint Engineer will propose and implement solutions concerning quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. The incumbent will help ensure the uniform and timely closure of product complaints for the specific manufacturing site by processing and closing product complaint files in accordance with established procedures.
Bachelor’s Degree in a technical discipline (e.g. EE, ME, BME, microbiology, chemistry, quality assurance), or equivalent knowledge.
Minimum of 2 years of experience in a medical device manufacturing environment.
Specific experience in complaint-handling activities.
Experience with supporting quality system procedures and policies in compliance with 21 CFR 820, CFR part 803,93/42EEC and related international reporting regulations.
Experience working with quality systems, GMP requirements, ISO requirements and other applicable international requirements for complaints management.
Strong verbal and written communication skills.
Strong analytical, organizational, communication and interpersonal skills.
Strong computer skills; working knowledge of MS Office 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 Surgical Technology America
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
Olympus Surgical Technology America at http://www.olympus-osta.com/
RA Manufacturing Engineer
Bartlett Gyrus ACMI LP
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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.