Quality Specialist

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

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

Job Description

This position is responsible for maintaining records and supporting day-to-day quality system activities. The primary purpose of the role is to facilitate the Quality team in the administrative aspects of work to maintain the Quality System, including scanning and filing of records, maintaining meeting and audit minutes, and change management. This is an entry level role which will provide the applicant with broad experience in a highly technical medical device manufacturing facility.

Job Duties

• Interpret and comply with company Standard Operating Procedures, and ensure records are compliant with all procedural requirements.
• Support preparation of records for CAPA Review Board (CRB), Key Performance Indicator (KPI) Review, and Management Review, and facilitates the planning and execution of these reviews.
• Support audit preparation, execution and generation of records. May serve as an audit coordinator, scribe or other functions as assigned by Site Quality Manager.
• Developing and collaborating on new and/or revised processes to seize opportunities for improvement.
• Maintain user access to the Agile Product Lifecycle Management system by submitting Agile Access Requests, coordinating with the site Training Specialist to obtain user training records as applicable.
• Create documents and change orders as assigned by Site Quality Manager.
• Monitor Change Management process to support timely completion of change orders; support change order originators where possible and communicate priority with reviewers.
• Support Quality team initiatives and projects as assigned by Site Quality Manager.

Job Qualifications

Required:

• High School Diploma required. BS degree in science or quality/regulatory preferred, or equivalent work experience.
• Minimum of 2 years of experience in a medical device company or equivalent regulated industry preferred. Experience in administrative roles, document control, etc. as applicable.
• Knowledge of Quality Management System standards (ISO 13485 and/or ISO 9001).
• Proven history of working independently and within teams to accomplish common goals.
• Ability to read, analyse and interpret Quality System documents and Records.
• Proficiency in Microsoft Office suite tools (Word, Excel, PowerPoint, and Outlook)
• Strong written and verbal communication skills are essential.
• Must be highly organized and detail-oriented, with the ability to maintain a constant influx of records and tasks.
• Typical business hours Monday - Friday, 8:00 AM to 5:00 PM. No travel required.

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 benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position in this location is $26.16 - $34.01 / hour, 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 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).

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)