Lead Engineer, Quality Investigation

2 weeks ago

Bartlett, Tennessee, United States Olympus Corporation of the Americas Full time

Location: Tennessee, Bartlett

Workplace Flexibility: Hybrid

For over a century, Olympus has dedicated itself to enhancing the health, safety, and fulfillment of individuals.

Every day, we embody our philosophy, True to Life, by advancing medical technologies and raising the standard of patient care, enabling people everywhere to achieve their aspirations and dreams.

Our five Core Values empower us to fulfill Our Purpose:

Patient Focus, Integrity, Innovation, Impact, and Empathy.

Job Overview

This role is accountable for managing intricate products, assisting the Complaint Investigation Technicians with product analysis and investigations, evaluating complaint trends, collaborating across functions to escalate product performance issues promptly, maintaining key performance indicators (KPIs) and metrics, supporting audits, and engaging in continuous improvement initiatives.

Key Responsibilities

  • Conduct thorough inspections of physical devices and perform failure analysis. Collaborate with cross-functional teams to ensure timely completion of complaint investigations. Present investigation results to both internal and external stakeholders.
  • Guide and mentor colleagues throughout the complaint investigation process, helping to eliminate obstacles to timely resolution.
  • Engage directly with customers and Olympus personnel to support complaint investigations and address customer concerns. Utilize investigation outcomes to create written communications for customers, ensuring consistent messaging on similar issues in coordination with internal stakeholders.
  • Review and authorize complaint investigation documentation promptly.
  • Develop guidelines and testing methods for product analysis related to complaints.
  • Act as a technical trainer for the Regional Investigation Center as necessary.
  • Formulate solutions for a variety of complex challenges where data analysis requires assessment of identifiable factors. Exercise judgment within generally defined practices and policies to select methods and techniques for obtaining solutions.
  • Lead corrective and preventive action (CAPA) initiatives. Implement systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic non-conformance issues.
  • Oversee and execute Non-Conformance Reports.
  • Collaborate with manufacturing sites to facilitate corrective and preventive actions regarding quality issues identified through complaint investigations or other quality data sources.
  • Assist local management in evaluating process implementation and provide recommendations to overcome processing challenges, enhance productivity, and improve workflow.
  • Support local process implementation and global continuous improvement initiatives by serving as a subject matter expert in complaint processing, particularly in physical device inspection, complaint investigation, and data analysis.

Qualifications

Essential:

  • A bachelor's degree in a technical field (e.g., Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Quality Assurance) or equivalent knowledge.
  • A minimum of 5 years of experience addressing regulatory or quality assurance matters in the medical sector, with specific experience in complaint-handling activities. Familiarity with Quality System Requirements (21 CFR 820 & 803) is mandatory.
  • Prior experience with various complaint handling systems, such as ETQ, SAP, Datasweep, or Salesforce.
  • Strong written and verbal communication skills.
  • Excellent analytical, organizational, communication, and interpersonal abilities.
  • Proficient in Microsoft Office Suite.
  • Previous experience with CAPAs, NCRs, and other quality management system functions.
  • Willingness to travel to customer sites for product evaluations, approximately 10% of the time.
  • Willingness to travel to manufacturing sites for product training, approximately 5% of the time.

Why Join Olympus?

We provide a comprehensive employee experience that supports personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings:

  • Competitive salaries, annual bonuses, and 401(k) with company match.
  • Comprehensive medical, dental, and vision coverage effective from the start date.
  • 24/7 Employee Assistance Program.
  • Access to 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, and Fitness Center.

Connected Culture:

  • A work-life integrated culture that supports an employee-centric mindset.
  • Options for 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.

Olympus is committed to building a diverse, inclusive, and authentic workplace.

We recognize the value of diversity in people, perspectives, and lifestyle choices, emphasizing the importance of inclusion and mutual respect. We strive to foster empathy and unity in the workplace, enabling our employees to contribute fully and thrive.

Let's realize your potential, together.

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