Senior Quality Engineer (Onsite)

Job Description

The Product Quality Engineer is responsible for the design, development and management of projects for legacy products. The Product Quality Engineer provides organizational support with a focus on Design Quality activities.

Works with internal / external manufacturers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies and procedures and medical device regulations.

The Product Quality Engineer will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations.

Job Duties

• Drive the design & execution of Production Release Process project for components & finished devices.
• Lead and implement complex projects including quality improvement initiatives.
• Sets direction for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Lead Process / Design Risk Analysis.
• Provide leadership in understanding of the quality regulations to other disciplines.
• Lead multiple product Design Control activities for new product development efforts.
• Support Process / Design Validation / Verification activities and approach including software validation.
• Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting.
• Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Job Qualifications

Required :

• Bachelor’s Degree in Engineering required.
• Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
• Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135, EUMDR and Human Factors.
• Strong working knowledge of technical problem solving via Six Sigma type tools to analyze, drive root cause, and solve problems.
• Proven track record in Sustaining Engineering, support of commercialized products and Post Market Surveillance.
• Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
• Up to 10% domestic travel

Preferred :

• Strong written and oral communication skills.
• Ability to thrive in a fast-paced, dynamic and deadline-driven environment.
• Well organized, flexible self-starter, team motivated and excellent at prioritizing and multi-tasking.
• Skilled in presentation development and public speaking.

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 culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Café, Fitness Center
• US Only Limited locations
23 days ago