Engineer, Principal Quality Assurance (Hybrid)

Working Location: MINNESOTA, BROOKLYN PARK 

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

Develop, maintain, and support the company Quality System, regulatory requirements and business strategy. Continuously improve Quality performance related to New Product Development, procurement, manufacturing, and metrics related to the strength of the site Quality System. Leads complex projects. Mentors less experienced engineers within and across OSTA sites in best practices for the use of Quality tools and methods. Expected to serve as a backup to the Management Representative for the location.

Job Duties

• Leads and participates in Cross-Functional Teams to support new product development, procurement, manufacturing representing Quality Engineering discipline.
  • Completes assigned Quality Engineering tasks to schedule.
  • Leads promotion of Quality and Regulatory requirements.
  • Leads or participates in the development of process and procedure development/changes.
  • Provides resident expertise in the application of Quality Sciences including statistics, data analysis, problem solving, and the creation of system solutions.
  • Develops new approaches to solve problems identified as part of the team.
  • Assists others to lead and develop novel approaches within the 5E teams.
• Leads the implementation. compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures for the site.
• Trains location personnel on all aspects of the Quality System and regulatory standards.
• Serves as a mentor and advisor for the Quality team to assist in developing Quality Engineering skills and capabilities.
• Applies the requirements of the Quality System to processes, products or services for the location.
  • Leads, supports, and guides the manufacturing line to address quality issues and resolution using the best Quality techniques and principles .
  • Develops and maintains the validation and verification strategy for new and existing products and processes.
  • Leads the development and maintenance of Master Validation Plans.
  • Participates in the CAPA process as required as an assignee or project team member.
  • Monitors product and process performance metrics and acts upon trends with minimal guidance.
  • Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labelling, etc.
  • Conducts internal, vendor, and process audits to schedule. 
  • lnterface with suppliers to resolve Quality issues.
• Develops and drives measurable Quality improvements relating to products, processes and services.
• All other essential related duties as required

Job Qualifications

Required:

• Bachelors degree in Engineering discipline or equivalent. Masters Degree preferred.
• Minimum of 8 years related experience, preferably in the medical device industry related to process/quality engineering.
• Viewed as an expert in the quality field.
• Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485-2003 and the ability to educate others on related subject matter.S trong Quality Science skills including demonstrated statistics application and problem solving 

 

Preferred:

• Leadership experience; proven ability to lead and manage cross-functional teams, effectively communicate with all levels of management. and drive effective change.
• Excellent verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management 
• Proven Project Management skills, with ability to manage cross-functional team and produce results. 
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization and/or guidance exists.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehe