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Olympus Corporation of the Americas Executive Director, Global Digital Quality Assurance in Westborough, Massachusetts

Working Location: MASSACHUSETTS, WESTBOROUGH

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 position will be a member of the Global Software Leadership Team, a peer group of VPs, Executive Directors, Directors, establishing a harmonized software development quality system and maintaining compliance to the established Quality Management Systems. Position will be responsible for setting Quality and Compliance Strategy for the Digital Business, which will require interaction and influence with global regulatory bodies and continuing to stay current on a rapidly evolving technology driven business. This position will also be responsible for developing and implementing a world-class agile Quality system in support of the growing digital business. The individual in this role will represent Olympus organization on the industry committees focused on digital medical devices. The position will direct reports and oversight responsibilities for digital products and QMS in Japan, Americas, and EMEA.

Job Duties

  • Develop and drive quality strategy in the digital space.

  • Develop and implement a World-Class QMS in support of Digital medical device development.

  • Working closely with the stakeholders, lead an organization responsible for Quality Deliverables for New Product in the development pipeline.

  • Establish critical to quality measures and implement monitoring mechanisms to ensure highest quality output.

  • Define, build, and develop a future Quality organization to support growing needs of the Digital business.

  • Ensure compliance to domestic and international regulations and guidance as well as compliance to harmonized standards such as ISO 62304 software life cycle and Software Risk Management.

  • Lead SW Quality management review process and ensure key quality indicators are met.

Job Requirements

REQUIRED QUALIFICATIONS:

  • Bachelor of Science in technical discipline is required. MBA or Master of Science in electrical engineering, computer science, software engineering, information systems, or software engineering is preferred.

  • Minimum of 12 years of experience in smart devices or software development.

  • Participation on software committees such as IMDRF or standards committees.

  • Strong understanding of controls for class II and III software based medical devices required.

  • Travel as job requires, both domestic and international travel Availability to attend international meetings.

PREFERRED QUALIFICATIONS:

  • Medical devices with Software experience strongly preferred.

  • Experience in leading teams and track record of developing Quality Systems in support of digital, software driven devices.

  • Systems engineering including: software, hardware, product security, information systems, SaMD and SaaS preferred.

  • Participation on an AI, SaaS, SaMD product development team preferred.

  • Participation on an international leadership team, Experience with computer aided diagnostic software and device controls preferred.

  • Experience with IT strategy and management Background in Artificial Intelligence development preferred.

  • Background in SaaS and SaMD development preferred.

  • Knowledge of hospital information system integration preferred.

  • Knowledge with product security regulations and standards (GDPR, NIST etc.) preferred.

#LI-JG

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 requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

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) || Westborough ||

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