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Olympus Corporation of the Americas is seeking a manager for the Health Hazard Assessment (HHA) team. This role includes overseeing engineers, ensuring completion of assessments, and providing risk management expertise. Applicants should have a technical degree and at least 10 years of experience in a regulated industry, with strong skills in risk management and project leadership. A commitment to patient care and regulatory excellence is essential.
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Working Location:NATIONWIDE
Workplace Flexibility:Field
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 ofpatient care so people everywhere can fulfill their desires, dreams, and lives.
Our fiveCore Valuesempower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
The position will manage HHA engineers to ensure timely and through completion of Health Hazard Assessment (HHAs) across Olympus globallywork with cross functional teams to complete HHAs across Olympus globallyserve as post market risk management expert to the HHA engineers and cross functional teamsserver as HHA Chair delegate when needed.
Manages HHA engineers to ensure timely and thorough completion of HHAs.
Works with cross-functional team to manage and track HHAs through to completion.
Ensures 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.
Delegates as chair of HHA board when needed.
Provides input and post-market risk management expertise to HHA teams.
Provides other project support to Management as necessary.
Leads and facilitates NCs and/or CAPAs for the HHA process as needed.
Required:
Bachelor’s Degree or equivalent in a technical or science-related field.
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.
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.
Flexible working hours across multiple time zones, due to the Global nature of this role.
Some domestic and international travel.
Ability to influence across multiple sites.
Preferred:
Experience in operational excellence and continuous improvement activities (desired).
Knowledge of Risk Management practices and regulatory requirements such as FDA QSRs, ISO 13485, ISO 14971, and 21 CFR 820 (preferred).
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
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
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
The anticipated base pay range for this full-time position working at this location is$117,068.00-$163,896.00/ 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 positionincluding: level of experience, working location, and relevanteducation 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 .
You Belong at Olympus
We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact 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).
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.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley ||Quality & Regulatory Affairs (QA/RA)
Job Segment: Manager, QA, Quality Assurance, Management, Technology, Quality