Quality Engineer - CAPA Site Lead

Req ID: 10344

Working Location: WASHINGTON, REDMOND

Workplace Flexibility: Hybrid

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

The position ensures consistent oversight and execution of Corrective and Preventive Action (CAPA) processes across the organization, supporting compliance with regulatory requirements and quality standards. The role provides expertise in the full CAPA lifecycle, including issue identification, containment, risk assessment, root cause analysis, action planning, implementation, and verification of effectiveness, while integrating risk management principles and aligning with broader quality systems. The position serves as a key resource for regulatory and audit readiness, ensuring CAPAs are defensible and effectively closed.

Additionally, the role drives cross-functional collaboration, facilitating structured problem-solving sessions, lessons learned, and continuous improvement initiatives across manufacturing, QA, QC, engineering, DA, R&D, PMS and supply chain functions. Through mentoring, coaching, and influencing without direct authority, the role strengthens analytical and systemic thinking within teams, promotes best practices, and fosters a culture of accountability and data-driven decision-making. The position also manages multiple CAPA projects, ensuring timely closure, effective prioritization based on risk, and adherence to defined timelines and metrics.

This role requires strong expertise in electronic Quality Management Systems (eQMS) such as Agile, SAP, TrackWise, along with proficiency in data analytics tools including Excel, Power BI, and Minitab for trend analysis and tracking CAPA effectiveness. A thorough understanding of document control and change management processes is essential to ensure compliance and maintain quality system integrity. The position also emphasizes a metrics-driven and continuous improvement approach, including monitoring CAPA KPIs (e.g., on-time closure rate, recurrence rate, overdue CAPAs), identifying system-level trends, proposing proactive improvements, and integrating CAPA learnings into training programs and standard operating procedures to enhance overall process performance.

Job Duties

Lead Technical and monthly CAPA CNRB meetings.
Upskill, mentor and coach CAPA teams.
Facilitate Process and System Trainings on Site or virtual as required.
CAPA (Process) Approver reviewing CAPA content for quality and completeness.
Monitor site level CAPA performance and deliverables to improve consistency and execution across all events.
CAPA SME in QMR, CNRB, Data Analysis.
Deep understanding of CAPA process lifecycle - from issue identification, root cause analysis, action planning, implementation, and verification of effectiveness.
Strong grasp of risk management principles and how CAPA integrates with quality systems (e.g., change control, deviations, complaints, audits).
Proficiency with RCA tools (5 Whys, Fishbone (Ishikawa) diagrams or other structured problem-solving methodologies).
Skilled at facilitating cross-functional RCA sessions.
Knowledge of applicable regulations and standards, such as: FDA 21 CFR Parts 210, 211, 820 or ISO 9001 / ISO 13485.
Experience with audit and inspection readiness; able to defend CAPAs and demonstrate robust closure.

Job Qualifications

Required:

Minimum of 7-9 years of experience in Quality, with 3-5 years leading CAPA or quality system.
Experience as QA Manager, Quality Engineer, Compliance Lead.
Strong communicator; able to work effectively with manufacturing, QA, QC, engineering, and supply chain.
Facilitate cross-functional “lessons learned” sessions to enhance record quality.
Partner with other sites and the Global CAPA CoE to identify and address systemic or recurring issues.
Builds accountability across teams and drives timely CAPA closure.
Able to influence behaviours and culture around continuous improvement.
Skilled in coaching others on CAPA principles and data-driven decision making.
Mentor investigators and approvers to strengthen analytical and systemic thinking capabilities.
Promote best practices and continuous learning.
Proficient in tracking CAPA timelines, deliverables, and metrics.
Ability to manage multiple CAPAs concurrently and prioritize based on risk.
Travel will be approximately 5%.

Preferred:

Bachelor of Science preferred.

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 $106,374.00 - $148,923.00 / 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 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)

Nearest Major Market: Seattle
Nearest Secondary Market: Bellevue
Job Segment: CAPA, Quality Engineer, Quality Assurance, QA, QC, Management, Engineering, Quality, Technology

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