Engineer II, Complaint Investigation (Hybrid)

Req ID: 9795

Working Location: CALIFORNIA, SAN JOSE

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.

Job Description

The Market Quality Engineer II position is responsible assisting in the evaluation and investigation complaints and reportable events at several levels. Interfaces closely with internal/external manufacturers, OEMs and local departments to promote quality improvements to both products and quality system processes by initiating and driving corrective and preventive actions. This position requires a thorough understanding of FDA regulatory requirement for complaint handling and MDR reporting. Must be able to communicate and follow-up on event description detail with internal and external customers to evaluate adverse event occurrences. Provides supports in the continuous improvement effort of the MBC and SBC quality systems for processing complaints to meet FDA, ISO and all applicable international regulatory requirements, and corporate guidelines. Proposes solutions concerning quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. Performs timely closure of product complaints in accordance with established procedures.

Job Duties

Perform physical device inspection and root cause failure analysis. Interact with cross-functional teams to ensure complaint investigation is completed in a timely manner. Communicate investigation findings to internal and external stakeholders.
Communicate directly with customers and Olympus field personal to support complaint investigation and resolve customer concern. Use investigation findings to generate written customer communications.
Review complaint records for accuracy and completeness. Perform complaint file closure in a timely manner. Identify, and assist in removing, roadblocks to timely file closure.
Provide technical support to Market Quality technicians, administration staff and production shop floor staff relative to technical investigations. Serve as a technical trainer to the Market Quality team members as needed.
Develop solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Support corrective and preventative action (CAPA) activity. Apply systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving systemic non-conformance.
Work directly with manufacturing sites to facilitate corrective and/or preventive actions related to quality problems identified through complaint investigation and/or other sources of quality data. Review and approve manufacturer’s investigations for accuracy and relevance to reported complaints.
Routinely develop and run reports in database systems for the purpose of trend monitoring and/or complaint investigation. Take appropriate steps to communicate with responsible parties to resolve issues. Reviews associated complaint records to ensure the applicable assessment, investigation and analysis records are appropriate and complete.
Perform other related duties as assigned.

Job Qualifications

Required:

A four-year degree in a technical discipline (e.g. EE, ME, BME, Quality Assurance), or equivalent knowledge.
Minimum of 2-5 years experience dealing with regulatory or quality assurance issues in the medical industries. Specific experience in complaint-handling activities. Knowledge of Quality System Requirements (21 CFR 820 & 803) is required.
Previous experience working with different complaint handling systems, e.i. ETQ, SAP, Datasweep Salesforce
Effective written and verbal communication skills.
Strong analytical, organizational, communication and interpersonal skills are required.
Computer literate with experience in Microsoft Office Suite
Available to travel to customer sites for product evaluation, ~10%
Available to travel to the manufacturing sites for product training, ~5%

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 $84,562.00 - $114,159.00 / 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 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 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) || California (US-CA) || San Jose || Quality & Regulatory Affairs (QA/RA)

Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto
Job Segment: QA, Quality Assurance, Manufacturing Engineer, CAPA, Database, Technology, Quality, Engineering, Management

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