Principal Quality Engineer

About the role

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.

Responsibilities

• 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.
• Ability to 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
• Leverages extensive technical experience to support high visibility new product development, sustaining engineering and CAPA efforts as assigned by Management
• Supports 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.
• Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio).
• Strong track record of leading and influencing without direct authority across functional groups, leadership levels and regions globally.
• Strong track record of leading and influencing without direct authority across functional groups, leadership levels and regions globally.

Preferred

• Minimum of 3 years’ experience working in Medical Device or Pharma.
• Six Sigma Black Belt is preferred.

Benefits

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings include competitive salaries, annual bonus and 401(k) with company match, comprehensive medical, dental, vision coverage, 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, onsite, hybrid and field work environments, paid volunteering and charitable donation/match programs, Employee Resource Groups, dedicated Training Resources and Learning & Development Programs, and Paid Educational Assistance.

Pay

The anticipated base pay range for this full-time position is $106,402.00 - $148,963.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.

Schedule

Remote

Location

Nationwide

Equal Opportunity Employer

We are 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).

Posting Notes

United States (US) | Pennsylvania (US-PA) | Center Valley | Quality & Regulatory Affairs (QA/RA)