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Senior Manager, Health Hazard Assessment - Remote

Req ID:  9231

Working Location: PENNSYLVANIA, CENTER VALLEY; NATIONWIDE 

Workplace Flexibility: Hybrid

 

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

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

Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

The position will:

  • manage HHA engineers to ensure timely and through completion of Health Hazard Assessment (HHAs) across Olympus globally
  • work with cross functional teams to complete HHAs across Olympus globally
  • serve as post market risk management expert to the HHA engineers and cross functional teams
  • server as HHA Chair delegate when needed

Job Duties

  • Manages HHA engineers to ensure timely and through completion of HHAs
  • Works with cross functional team to manage and track HHAs through to completion.  
  • Ensure HHA target completion is achieved.  Works to meet key performance indicators.
  • Provides input into process documents (e.g. procedures, work instructions, templates, etc.) to ensure HHA process is being executed effectively and timely 
  • Delegate chair of HHA board when needed 
  • Provide input and post market risk management expertise to HHA teams. 
  • Provide other project support to Management as necessary
  • Leads and facilitates NCs and / or CAPAs for the HHA process as needed

Job Qualifications

Required:

  • Bachelor’s Degree or equivalent in a technical or science-related field is required.
  • Minimum 10 years’ experience working in finished medical device or related regulated industry with strong concentration in risk management, Health Hazard Evaluation, and/or Field Corrective Actions.
  • Minimum of 5 years of people management experience.
  • Flexible working hours across multiple time zones, due to the Global nature of this role. Some domestic and international travel.

 

Preferred:

  • Experience in operational excellence and continuous improvement activities desired.
  • Knowledge of Risk Management practices and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971 & 21 CFR 820 is preferred.
  • Ability to influence across multiple sites.
  • Must be self-motivated with a strong sense of urgency to solve issues.
  • Ability to consistently deliver on required activities and meet assigned deadlines.
  • Demonstrated ability to manage and complete multiple projects and assigned objectives.
  • Prior experience leading cross-functional teams.
  • Excellent verbal and written communication skills, including public speaking and facilitation.
  • Excellent interpersonal skills and experience working with different personalities, cultures, and levels of management.

Why join Olympus?

 

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

 

Equitable 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 mindset

  • Offers onsite, hybrid and field work environments

  • Paid volunteering and charitable donation/match programs

  • Diversity Equity & Inclusion Initiatives including 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 our team?

 

Learn more about our benefit and incentives.

 

The anticipated base pay range for this full-time position working at this location is $114,213.00 - $159,898.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications. 

 

At Olympus, 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 healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. 

 

For more than 100 years, Olympus 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, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, 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.

 

Olympus is dedicated to building a diverse, inclusive and authentic workplace

 

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

 

Let’s realize your potential, together.

 

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.

 

Applicants with Disabilities:

 

As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

 

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) 


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

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