Quality Engineer I

Olympus Corporation of the Americas; Redmond (WA); On-site; USD 66,000 - 91,000; Full time

Job summary

Olympus Corporation of the Americas is seeking a Quality Engineer I to provide Quality Engineering support for compliance with the Quality Management System. This entry-level position offers opportunities for growth and responsibilities related to auditing, corrective actions, and training within a global medical technology leader based in Redmond, WA.

Benefits

Competitive salaries

Annual bonus

401(k) with company match

Comprehensive medical, dental, vision coverage

24/7 Employee Assistance Program

Generous Paid Vacation and Sick Time

On-Site Child Daycare

Café and Fitness Center

Qualifications

• Bachelor's degree or equivalent in engineering discipline required.
• 2 years minimum experience in any engineering position preferred.
• Knowledge of 21 CFR Part 820 preferred.

Responsibilities

• Ensure compliance of the OAI Quality Management System.
• Support preparation of change orders and maintenance of Quality Management System.
• Coordinate and investigate identified Nonconformances.

Skills

Problem solving

Analytical skills

Communication

Education

Bachelor's degree in engineering

Biomedical Engineering

Bioengineering or Mechanical Engineering

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Working Location:Washington, Seattle

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 ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our fiveCore Valuesempower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus.

Job Description

The Quality Engineer I is a role that provides Quality Engineering support to ensure compliance with the Quality System and business strategy of Olympus. They are a representative of the Quality Department specifically allocated to supporting Quality Management System compliance and QA Distribution processes and responsibilities. The Quality Engineer I has responsibilities for various aspects of the Quality System from Audit Readiness, Corrective/Preventative Action, Nonconforming Material, Training and Document Control and may be called upon to support Global Ship Hold activities. They support the Director, Site Quality Systems with ensuring compliance to the Quality Management System.

This job is intended to provide the applicant with a mixed experience through supporting roles designed to give them increasing autonomy and the opportunity to take on more responsibility over time. They will support the Director and other Quality Engineers with maintaining core processes and meeting key performance metrics, while simultaneously implementing new procedures. This role will primarily focus on day-to-day compliance requirements. The balance of their time will be allocated to other projects and operations of the department.

Job Duties

• The Quality Engineer I ensures compliance of the OAI Quality Management System
• All Quality Engineers in one manner or another are responsible for:
• Support preparation of change orders to part specifications, drawings, and inspection plans.
• Support the ongoing maintenance of the Quality Management System by revising SOPs, work instructions, and forms as assigned. Coordinate training and assist in development of training materials working directly with the site Training Specialist. Supports Document/Change control. Promotes Awareness of Quality and Regulatory requirements.
• Support Quality Engineers in the hosting and execution of Material Review Board (MRB) meetings and activities.
• Coordinate and Investigate identified Nonconformances. Generates Non-conformance Reports (NCRs) Document the investigation, affected lots/materials/processes, and any necessary escalations, and determine the required approvers.
• Complete Corrective Action and Preventive Action (CAPA) tasks as assigned, and support other Quality Engineers in CAPA Coordination. Conduct and document investigations, participate in Root Cause Analysis, document corrective / preventive actions, document verification of effectiveness of corrective and/or preventive actions.
• Meet Key Performance Indicator (KPI) targets for NCRs, CAPAs, Training, and other site quality metrics.
• Supports Distribution Operations as assigned.
• Assist in hosting internal and external audits according to approved schedule, or external audits (e.g., FDA Inspections and MDSAP / ISO 13485 surveillance audits with Notified Body)

Job Qualifications

Required:

• Bachelors’ degree or equivalent in an engineering discipline is required.Biomedical Engineering highly preferred.
• Experience with risk.
• Identifying requirements, setting realistic schedules, and meeting deadlines.
• Ability to identify issues determine root cause and implement solutions.
• High level of proficiency in Microsoft Word, Outlook, Excel, and PowerPoint required.
• High level of verbal and written communication skills.

Preferred:

• Bioengineering, Mechanical Engineering, etc. with relevant educational experience for medical device industry preferred. Evidence of continued learning efforts a plus.
• 2 years minimum’ experience operating in any Engineering position, preferably Quality Systems Engineering in a highly regulated environment (medical devices, biotech, pharmaceuticals, etc.) is optimal.
• Knowledge of 21 CFR Part 820 preferred, with knowledge of 93/42/EEC Medical Devices Directive, SOR 98/282 Canadian Medical Device Regulations, ISO 13485, and any other medical device industry international standards a plus.
• Formal education developing problem solving skills, analytical skills. Specific tolls such as process mapping, histograms, FMEA, Cause and Effect Diagrams, etc. preferred.
• Visio skills desirable. Experience with statistical analyses a plus.

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

Are you ready to be a part of our team?

Learn more about our benefit and incentives.

The anticipated base pay range for this full-time position working at this location is$66,974.00-$90,414.00/ 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 positionincluding: level of experience, working location, and relevanteducation 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 value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.

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.

Posting Notes: || United States (US) || Washington (US-WA) || Redmond ||Quality & Regulatory Affairs (QA/RA)