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Analyst, Quality Assurance

Req ID:  728

Working Location: MEXICO, MEXICO CITY 

 

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

<span style="font-family:"Arial Unicode MS",serif"><span style="font-family:"Arial",sans-serif">This position will act as the subject matter expert (SME) for the Quality Management System and to support Market Quality activities in Mexico. The incumbent will be responsible for building a bridge between the Corporate QMS and Olympus Mexico’ QMS by creating and implementing procedures to assure alignment with Global Quality Management System.  As part of this function, this individual may also act as the Sanitary responsible or <span style="font-family:"Arial",sans-serif">Technovigilance representative<span style="font-family:"Arial",sans-serif"> for OMS. The incumbent will further initiate and perform routine and periodic assessment audits/activities appropriate to the QMS to ensure quality compliance is maintained. Also, support RA activities on an as needed basis.

Job Duties

<span style="font-family:"Arial Unicode MS",serif"><span style="font-family:"Arial",sans-serif">Act as the subject matter expert for the Quality Management System for OMS by mapping, developing, reporting and implementing procedures according with Corporate policies/procedures/ guidelines in the Region to meet customer and regulatory requirements. Write quality system SOPs, WIs, QM and other documents needed to support the Quality System, Performs quality system training and maintain training records and other quality records. <span style="font-family:"Arial Unicode MS",serif"><span style="font-family:"Arial",sans-serif">Actively address all product complaints and file MDRs/PAEs/vigilance submissions. Assists in handling customer complaints, returns, investigations and CAPA’s.

Job Requirements

Degree in biology, chemistry or a related field compatible with the requirements for a Sanitary Responsible representative in Mexico. Minimum 3 years in quality experience in a medical device environment. Experience working in quality management systems such as ISO 13485 or equivalent. Detail-oriented, self-motivated and able to work independently in a multi‑tasking environment, nternal quality auditing experience preferred, knowledge of international medical device requirements (Other countries in LATAM) is preferred.

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.

The Olympus Latin America Division (LAD) encompasses three subsidiaries within Olympus Corporation of the Americas including Olympus Latin America, Olympus America de México, and Olympus Optical do Brazil. Throughout their respective regions, each subsidiary manages Olympus’ operations, distributor partnerships, and workforces in roles such as sales, marketing and support functions. For more information, visit olympuslatinoamerica.com and truetolife.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: || Mexico (MX) || Distrito Federal (MX-DIF) || Mexico, D.F. || 


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