Senior Engineer, Complaint Investigation

Working Location: MINNESOTA, BROOKLYN PARK; CALIFORNIA, SAN JOSE; TENNESSEE, BARTLETT 

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

This position is responsible for owning complex products, supporting the Complaint Investigation Technicians on the complaint product analysis and investigations, analyzing complaint trends, working cross-functionally to escalate product performance issues in a timely manner, maintaining green KPIs and metrics, supporting internal and external audits and participating in process continuous improvement initiatives.

Job Duties

• Perform physical device inspection and cause failure analysis.  Interact with cross-functional teams to ensure complaint investigation is completed in a timely manner. Communicate investigation findings to internal and external stakeholders.
• Guide and support colleagues in the complaint investigation process, assisting to remove roadblocks to timely investigation completion.
• Communicate directly with customers and Olympus field personal to support complaint investigation and resolve customer concern. Use investigation findings to generate written customer communications. Ensure consistent messaging to customers on similar concerns, coordinating with internal stakeholders to review content of communication.
• Review and approve complaint investigation records in a timely manner.
• Develop Product Analysis Guidelines and test methods to analyze complaints.
• Serve as a technical trainer to the Regional Investigation Center as needed.
• Develop solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Lead corrective and preventative action (CAPA) activity. Apply systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving systemic non-conformance.
• Own and execute Non-Conformance Reports.
• Work directly with manufacturing sites to facilitate corrective and/or preventive actions related to quality problems identified through complaint investigation and/or other sources of quality data.
• Assist local management team in reviewing process implementation and provide recommendation to resolve processing challenges, increase productivity and improve workflow.
• Support local process implementation and global continuous improvement initiatives by serving as a subject matter expert in the field of complaint processing on topics relating to physical device inspection, complaint investigation and data trending.

Job Qualifications

Required:

• A four-year degree in a technical discipline (e.g. EE, ME, BME, Quality Assurance), or equivalent knowledge.
• Minimum of 5 years experience dealing with regulatory or quality assurance issues in the medical industries.  Specific experience in complaint-handling activities. Knowledge of Quality System Requirements (21 CFR 820 & 803) is required.
• Previous experience working with different complaint handling systems, e.i. ETQ, SAP, Datasweep  Salesforce
• Effective written and verbal communication skills.
• Strong analytical, organizational, communication and interpersonal skills are required.
• Computer literate with experience in Microsoft Office Suite
• Previous experience working with CAPAs, NCRs, and other quality management system functions. 
• Available to travel to customer sites for product evaluation, ~10%
• Available to travel to the manufacturing sites for product training, ~5%

 

#LI-Hybrid

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 class