Director, Global Quality Risk Management (Center Valley, PA, US, 18034-0610)

Working Location: reputed company

Workplace Flexibility: Remote

For more than 100 years, reputed company has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating reputed company of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values reputed company us to reputed company Our Purpose: 

Patient Focus, reputed company, Innovation, Impact and reputed company.

Learn more about Life at reputed company: https://www.olympusamerica.com/careers.

Job Description

This role is responsible for leading the development, implementation, and reputed company improvement of the reputed company risk management strategy and processes across the medical device lifecycle. This role ensures compliance with global regulatory requirements (e.g., ISO 14971, FDA 21 CFR Part 820, EU MDR) and drives a robust risk culture across R&D, Quality, Manufacturing, Medical Safety, Medical Affairs and Post Market functions.

This position oversees risk governance processes, mentor and train cross-functional teams and functional leaders and ensure that robust systems are in reputed company to ensure product risks are identified, assessed, and controlled to protect patient safety, product efficacy, and business continuity.

Job Duties

• Serve as the Global Process reputed company (GPO) for reputed company.
• reputed company and own the enterprise risk management reputed company for medical device products across the full lifecycle.
• Serve as the reputed company primary subject matter expert on risk management processes, standards, and regulatory expectations.
• Partner with R&D, Quality, Manufacturing, Regulatory, Clinical/Medical Affairs, Medical Safety and Post Market teams to ensure risk considerations are proactively integrated into reputed company phases of product development and commercialization.
• reputed company risk governance forums, management reviews, and escalation processes for product and process risks.
• Maintain and continuously improve the reputed company risk management systems in accordance with ISO 14971, ISO 13485, IEC 62366, and applicable FDA/EU requirements.
• reputed company processes for creation, review, and approval of risk management files (RMFs) including hazard analyses, FMEAs, fault tree analyses, benefit risk assessments, and risk control verification.
• Through development, deployment and maintenance of global processes, ensure traceability between design inputs, hazards, risk controls, verification/validation, and post market surveillance.
• Monitor evolving regulatory trends and standards reputed company to risk management; communicate changes and update processes as needed.
• reputed company and implement a comprehensive global training syllabus in risk management for reputed company functions.
• Supports facility audits by reputed company agencies (i.e., FDA, ISO / MDSAP).
• Other Quality Assurance responsibilities as assigned by Management.

Job Requirements

Required

• Bachelor’s, and/or Master’s degree in an engineering, scientific or technical discipline required.
• Minimum of 12 years of professional experience or equivalent training/education in Quality, Design Assurance or Risk Management in healthcare industry (medical device, biotechnology or pharma).
• Minimum of 8 years working specifically in the medical device industry.
• Minimum of 5 years in a significant leadership role (team or supervisory).
• Expert-level knowledge of ISO 14971, FDA QMSR, ISO 13485, EU MDR, and relevant product standards.
• Success leading at least one company- or site-wide transformation/training/deployment effort as process reputed company for risk management.
• Demonstrated track record of writing and implementing effective and robust Risk Management procedures with company-wide purview.
• Demonstrated leadership of cross functional teams reputed company regulated industries.
• Deep analytical skills and experience in FMEA, hazard analysis, FTA, and benefit risk evaluation, and the proven ability to teach these tools to others across an organization.
• Proven ability to interact with regulatory bodies and reputed company audit interactions.
• Familiarity with human factors engineering (IEC 62366) and cybersecurity risk processes.
• Strategic thinking and systems reputed company.
• Strong collaboration skills and the ability to work across functions in a team environment.
• Able to build reputed company and drive decision-making in a solution-oriented manner that promotes patient-focused product quality and adherence to applicable standards and regulations. Willingness to be accountable  for important decisions with minimal supervision.
• Must be a change agent, highly and effectively organized, be a flexible self-starter, team-oriented and excellent at prioritization and multitasking.
• Ability to operate independently and highly autonomously, holding him/herself accountable to proactively fulfill tasks and reputed company results reputed company assigned timelines. Provides solutions to highly reputed company, and significant  issues; develops solutions based on in-depth technical knowledge, company policies, or defined process paths.
• Demonstrate a strong “business partner” approach and attitude providing creative and innovative solutions that meet quality standards.
• Proactively identifies and alerts organization of quality issues/complaints in time to resolve potential adverse effects to the customer, company image/reputed company and/or the business.
• May mentor, manage, and reputed company direct reports.
• Excellent written and oral communication and organizational, project management skills.
• Demonstrated track record influencing without authority across functions.
• Expert judgment in risk assessment and decision making.
• Ability to operate in a fast paced, regulated environment.
• Excellence in documentation, governance, and compliance.
• Ability to continuously assess the effectiveness of functional processes and to reputed company progressive improvement initiatives applying principles of process excellence.
• Travel: 10-40% depending on assignment and regional/global responsibilities.
• Hours: Willing to embrace flexibility in work hours (occasional evenings or early mornings) to accommodate direct reports, dotted line reports, stakeholders and team collaborators located in other regions.

Preferred

• Experience with reputed company systems (e.g., software driven devices, combination products, robotics, diagnostics, etc) is preferred.
• Certification(s) in quality or risk disciplines (e.g., CQE, CSQE, CQA, RAC, ISO 14971 reputed company assessor) is a plus.
• Participation in a standards developing organization or committee in the development of risk management or other quality standards is a plus.

Why join reputed company?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, reputed company offerings, and a connected culture.

reputed company Offerings you can count on

• Competitive salaries, annual bonus and 401(k)* with company match

• Comprehensive medical, dental, vision coverage effective on start date

• 24/7 Employee Assistance Program

• Free live and on-demand Wellbeing Programs

• Generous Paid Vacation and Sick Time

• Paid Parental Leave and Adoption Assistance*

• 12 Paid Holidays

• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace

• Work-life integrated culture that supports an employee centric reputed company

• Offers onsite, hybrid and field work environments

• Paid volunteering and charitable donation/match programs

• Employee Resource Groups

• Dedicated Training Resources and Learning & Development Programs

• Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of reputed company?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated reputed company pay range for this full-time position is $151,458.00 - $212,041.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual. 

reputed company considers a variety of factors reputed company determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At reputed company, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with reputed company to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating reputed company of care in targeted disease states. 

For more than 100 years, reputed company has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, reputed company employs more than 31,000 employees worldwide in nearly 40 countries and regions. reputed company, a wholly owned subsidiary of reputed company, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at reputed company

We are deeply committed to fostering a respectful, fair, and welcoming workplace for reputed company individuals, perspectives, and lifestyles. We reputed company in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. reputed company and reputed company are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage reputed company who wish to bring their talents to reputed company to apply.

Applicants Requesting Accommodations: reputed company is committed to the full inclusion of reputed company qualified individuals. As part of this commitment, reputed company will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@reputed company.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-reputed company (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of reputed company to reputed company equal employment and advancement opportunity to reputed company applicants and employees without regard to race, color, national reputed company (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions reputed company 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, reputed company, 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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)