Olympus Corporation of the Americas logo
Olympus Corporation of the Americas

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Olympus is 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.

Principal Quality Engineer

EngineerEngineerFull TimeRemoteLeadTeam 5,001-10,000H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

28 days ago

Salary

$106.4K - $149.0K / year

Seniority

Lead

Job Description

Principal Quality Engineer

Olympus Corporation of the Americas

Role Description This role focuses on Product Quality and drives Patient Focus by leveraging problem-solving expertise and leadership acumen to accelerate product quality improvement, resolve issues, and ensure patient safety and customer satisfaction. Job Duties - Train, coach, and support CAPA Site Leads in the application of technical and analytical methods that accelerate CAPA closure and effectiveness. - Provide coaching for CAPA owners to drive the development of sound problem-solving and technical design review habits and techniques across Olympus. - Support the use of quality problem-solving tools such as Root Cause Analysis, 5 Whys, Ishikawa, etc. - Deploy and oversee a Design Assurance Quality Engineer training and development syllabus supporting the development of a patient-focused Quality Mindset and technical rigor across the Design Quality Assurance function. - Leverage extensive technical experience to support high visibility new product development, sustaining engineering, and CAPA efforts as assigned by Management. - Support high-priority complaint investigations, signal detection, and product issue escalations. - Other Quality Assurance responsibilities as assigned by Management. Qualifications - BS degree or equivalent in an engineering or life science discipline. - Minimum of 8 years’ experience working in an FDA regulated environment. - Demonstrated ability to manage and complete multiple projects and objectives and lead cross-functional teams. - Proficient with DMAIC/ Lean Six Sigma /Black Belt tools to analyze, drive root cause, and solve difficult problems. - Proficient with statistics, sampling strategies, quality systems trending, and process capability. - Proficient with Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDAQSRs, ISO 13485, ISO 14971. - Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities. - Strong track record of leading and influencing without direct authority across functional groups, leadership levels, and regions globally. - Excellent interpersonal, communication (written and oral), presentation, and facilitation skills. - Demonstrated ability to coach and mentor others. - Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio). - Demonstrates the highest ethical standards and actively promotes trust, respect, and integrity in all dealings both inside and outside the Company. - Six Sigma Green Belt Certification required. - Ability to travel up to 20% of time domestically and internationally. Requirements - Minimum of 3 years’ experience working in Medical Device or Pharma (preferred). - Six Sigma Black Belt is preferred. Benefits - 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. - 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. - Paid Educational Assistance.

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Job Closed