Director, Quality (Health Hazard Assessments)

Working Location: PENNSYLVANIA, CENTER VALLEY 

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Director, Health Hazard Assessment shall have direct leadership, accountability, and oversight of the Health Hazard Assessment (HHA) process.   The Director will, working with others, provide primary support for HHA activities to ensure Olympus develops data driven HHAs with robust issue analysis, and justified conclusions and summaries. The position is responsible for developing and implementing programs and policies to ensure HHA development and assessments occurs in a timely manner to address safety and compliance areas of our business and to ensure proper documentation are in place.   This position will be support and train Olympus resources to gain required HHA analysis and documentation skills and aligned to regulatory expectations.  Serves as primary subject matter expert for regulatory inspections, regulatory inquiries, and 3rd party audits.

Job Duties

• Manages day-to-day operation of the global HHA Program. 
• Ensure HHA deadlines are achieved and establish and meet key performance indicators.
• Maintain current knowledge of industry best practices and regulatory requirements as well as Olympus operations across the areas of HHAs and Field Actions, complaint handling, adverse event reporting, CAPA and Post Market Surveillance activities in support of HHA development and expert guidance for the HHA teams.
• Apply knowledge to develop processes, optimize processes, and suggest improvement to current processes as needed.
• Develops, initiates, maintains, and revises policies and procedures for the HHA Program and related activities in line with regulatory expectations.
• Works to prevent, detect, and correct compliance risks through designing, implementing, and monitoring policies, procedures, and internal controls related to respective compliance requirements in coordination with management and other parties.
• Manages, oversees, provides guidance and assists HHA Owners, providing consultation and recommendations on relevant product quality issues affecting the organization.  
• Day-to-day leader for the global HHA teams to aid in resolution of challenging and complex issues and removal of barriers to ensure timely and complete HHAs. Escalates to Global VP, Field Actions. 
• Responsible for successful preparation and timely distribution of completed HHAs to the Field Corrective Action (FCA) Review Board for FCA voting. 
• Responsible for working in partnership with Medical Safety, Regulatory, Complaint, CAPA, and Non- Conforming teams to identify, document and escalate, where necessary, situations requiring HHA analysis.  Collaborates with global/regional leaders on relevant HHAs and interacts with Legal and Compliance as required.
• Supports HHA inspections and is key internal HHA inspection leader in support of regulatory inspections.•Identify and lead decision making and escalation of fast track issues for immediate evaluation and decision making.
• Identify and manage internal and external resources, as necessary, to support the global HHA program and HHA teams.

Job Requirements

• A minimum of a 4-year college degree (Bachelor’s Degree) in engineering or scientific discipline is required.                                                 
• Master’s Degree or equivalent is preferred, with preferred areas of study being in the Scientific or Engineering discipline         
• 10+ years of professional experience in a medical device safety management role is required
• Demonstrated experience in developing and leading a top performing quality team is required.
• Proficient understanding of medical device regulations which include recalls/FCAs, complaint handling, and adverse event reporting is required.
• Strong analytical, organizational and communication skills required.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24/7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive c