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RA/QA SUPERVISOR-OMS • RA/QA

Req ID:  727

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 is responsible for overseeing local regulatory and quality system activities for Mexico, in cooperation with staff in the Olympus Latin America office in Miami, Florida. This function prepares final registration dossiers for submission to the Mexican regulatory agency (COFEPRIS) and acts as a liaison between Olympus Mexico (OMS) and COFEPRIS. As part of this function, this individual also acts as the Sanitary responsible representative for OMS and also as QA Management Representative for the QMS at OMS. Thus responsible for ensuring that OMS and 3rd party vendors working on behalf of OMS comply with all applicable regulatory and legal requirements in Mexico. This function is responsible for ensuring the identity, purity and safety of the products is maintained at any facility where Olympus product is serviced, stored or distributed in Mexico. This function supports the procurement, organization, logging and filing of regulatory documentation related to product registrations and vigilance activities in Mexico. May also support regional activities/projects.

Job Duties

<span style="font-family:"Arial Unicode MS",serif"><span style="font-family:"Arial",sans-serif">This position is key and principal duties are: acts as the Sanitary Responsible and Technical Vigilance representative for Olympus America de Mexico (OMS). Also, as the subject matter expert for Olympus Product registrations in Mexico.<span style="font-family:"Arial Unicode MS",serif"><span style="font-family:"Arial",sans-serif">Request, collect and review technical/legal documentation from OLA and/or Manufacturing Business Centers assuring its adequacy to the registration requirements in Mexico. <span style="font-family:"Arial Unicode MS",serif"><span style="font-family:"Arial",sans-serif">Maintain the product registrations and documentation databases (Ie: Endowise) and regulatory submission files. <span style="font-family:"Arial Unicode MS",serif"><span style="font-family:"Arial",sans-serif">Partner with cross functional teams providing regulatory guidance and support for strategic planning, design and compliance activities in regards to product registration in Mexico and/or other countries in the region, if is needed. <span style="font-family:"Arial Unicode MS",serif"><span style="font-family:"Arial",sans-serif">Hold regular meetings and prepare reports to be shared with different areas in the organization to communicate project status and milestones associated with product registration activities and other projects. between other key responsibilites

Job Requirements

 Degree in biology, chemistry or a related field compatible with the requirements for a Sanitary Responsible representative in Mexico, Minimum 5 year’s in regulatory and/or quality experience in a medical device environment, Experience working with COFEPRIS, registering class II & III medical devices, experience working in quality management systems such as ISO 13485 or equivalent. Knowledge of business and management principles, including performance management. Strong organizational skills with ability to prioritize workload and comfortable in a working from home arrangement,  detail-oriented, self-motivated and able to work independently in a multi‑tasking environment. strong presentation and communications skills in both Spanish and English, ability to work under pressure within time critical deadlines., internal quality auditing experience 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, 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 a global technology leader, crafting innovative optical and digital solutions in medical technologies; life sciences; industrial solutions; and cameras and audio products. Throughout our 100-year history, Olympus has focused on being true to society and making people’s lives healthier, safer and more fulfilling. 

Olympus Canada Inc. (OCI)—a subsidiary of Olympus Corporation of the Americas—manages the Company’s operations and workforce throughout Canada in roles such as sales, marketing, service, and support functions. Based in Richmond Hill, ON,  OCI is committed to developing our employees and supporting our local communities. For more information, visit olympuscanada.com and truetolife.com.
 

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

 

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

 

Posting Notes: || Mexico (MX) || Distrito Federal (MX-DIF) || Mexico, D.F. || 


Job Segment: Manager, Quality Manager, Scientific, Quality Assurance, QA, Management, Quality, Engineering, Technology

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