Quality Engineer II

Olympus Corporation; Minneapolis (MN); On-site; USD 79,000 - 107,000; Full time

Benefits offered by this job

Competitive salaries and annual bonus

401(k) with company match

Comprehensive medical/dental/vision

Employee Assistance Program

Paid vacation and sick time

Parental leave and adoption assistance

12 paid holidays

On-site facilities

Job summary

Olympus Corporation in Minnesota (Brooklyn Park) is seeking a Quality Engineer to support the Quality System, regulatory requirements, and business strategy. You will be a key team member for new product development, transfers, manufacturing support, and service of products.

You will promote quality awareness, lead process improvements, apply statistics to improve processes, and assist with validation, CAPA, and audits.

Qualifications

• Bachelor's degree in science/engineering; equivalent industry experience.
• Minimum 3 years related experience, preferably in the medical device industry.
• Knowledge of basic mechanical testing and material properties.
• Knowledge of metrology.
• Familiarity with U.S. FDA QSR requirements including ISO 9001, MDD93/42, ISO 13485-2016, and Canadian Medical Device requirements.
• Good statistical and analytical skills.
• Working knowledge of Problem Solving Tools: Process Mapping, PDCA, FMEA, etc.
• Working knowledge of Quality Tools: Basic Statistics, Technical Writing, Metrology & Calibration, Inspection and Testing, etc.
• Strong verbal and written communication in cross-functional teams.
• Proficiency with IT applications.

Responsibilities

• Serve as a cross-functional member to support new product development and manufacturing transfers.
• Complete assigned Quality Engineering tasks to schedule.
• Promote awareness of Quality and Regulatory requirements.
• Lead or participate in process and procedure development/changes.
• Apply statistical methods to evaluate processes and changes.
• Support CAPA process and root-cause investigations.
• Assist in implementation of standards (FDA QSR, ISO 13485) and QA policies.
• Train site personnel on Quality System and regulatory standards.
• Provide support to metrology and inspection methods; support validation strategies.
• Develop and maintain Product Master Validation Plans.
• Collaborate on quality improvements and drive measurable results.
• Interface with SQE to resolve issues and support audits.

Skills

Quality Engineering

Statistical methods

Metrology

Quality Tools

Regulatory knowledge

Problem solving

Technical writing

Auditing

Education

Bachelor's degree in science/engineering

Tools

FDA QSR familiarity

ISO 13485

Job description

Working Location: Minnesota, Brooklyn Park

Workplace Flexibility: Onsite

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Job Description

Provide Quality Engineering support to ensure compliance with the Quality System, regulatory requirements and the business strategy of the company. Represents Quality as a team member to support new product development, procurement, manufacturing, returns and servicing of products produced.

Job Duties

• Cross Functional Team member to support new product development product manufacturing transfers procurement on-going manufacturing and servicing processes representing Quality Engineering discipline.
• Completes assigned Quality Engineering tasks to schedule.
• Promotes awareness of Quality and Regulatory requirements.
• Leads or participates in the development of process and procedure development/changes.
• Applies statistical methodology to evaluate current processes and process changes.
• Develops new approaches to solve problems identified as part of the team.
• Assists in the implementation compliance and maintenance of standards (e.g. FDA IS0 13485) and OSTA Quality policies and procedures.
• Trains location personnel on all aspects of the Quality System and regulatory standards.
• Applies the requirements of the Quality System to processes products or services for the location.
• Supports the manufacturing line to address quality issues and resolution.
• Provides support to metrology component inspection methods and preventive maintenance programs.
• Supports validation and verification strategy for new and existing products and processes as assigned.
• Leads the development and maintenance of product Master Validation Plans.
• Participates in the CAPA process as required as a CAPA Lead or CAPA project team member.
• As requested by Market Quality function investigates escalated product complaints related to manufacturing issues to root cause to ensure timely customer response and correction.
• Monitors product and process performance metrics and acts upon trends (positive or negative). Leads MRB as a team member to ensure proper disposition of non- conformances.
• Authors collaborates and approves Quality System documentation including changes orders DHF DMR DHR labels and labelling.
• Supports site regulatory inspections internal audits or customer audits as requested Interfaces with SQE function to resolve Quality issues.
• Develops and drives measurable Quality improvements relating to products processes and services.
• All other essential duties as assigned.

Job Qualifications

Required:

• A minimum of a Bachelor's degree (B.S.) in science/engineering discipline.
• Equivalent industry experience.
• Minimum of 3 years related experience preferably in the medical device industry related to process/quality engineering.
• Knowledge of basic mechanical testing and material properties.
• Knowledge of metrology.
• Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001, MDD93/42, ISO 13485-2016, and Canadian Medical Device requirements.
• Good statistical and analytical skills.
• Working knowledge of Problem Solving Tools: Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.
• Working knowledge of Quality Tools: Quality Planning, Quality Costs and Assessment, Basic Statistics, Advance Statistical Techniques, Technical Writing, Metrology & Calibration, Inspection and Testing, Sampling Principles and AQL, TQM, Lean Six Sigma, etc.
• Strong verbal and written communication skills in a cross-functional team environment.
• Demonstrated ability to generate technical reports and the ability to make presentations to middle and upper management.
• Proficient in the use of Information Technology and applications.

Preferred:

• ASQ certifications in one or more of the following areas: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• 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**

Connected Culture you can embrace:

• 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
• US Only
• Center Valley, PA and Westborough, MA

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks

The anticipated base pay range for this full-time position in this location is $79,259.00 - $107,000.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are 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.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is 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 [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.