Location: San Jose, CA
Company: Olympus
over 100 years. Our Purpose is to make people’s lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View We deliver on our purpose and our core values by staying True to Life.
Job Description This position is responsible for owning complex products, supporting the Complaint Investigation Technicians on the complaint product analysis and investigations, analyzing complaint trends, working cross-functionally to escalate product performance issues in a timely manner, maintaining green KPIs and metrics, supporting internal and external audits and participating in process continuous improvement initiatives.
Job Duties Perform physical device inspection and 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. Guide and support colleagues in the complaint investigation process, assisting to remove roadblocks to timely investigation completion. Communicate directly with customers and Olympus field personal to support complaint investigation and resolve customer concern. Use investigation findings to generate written customer communications. Ensure consistent messaging to customers on similar concerns, coordinating with internal stakeholders to
review content of communication. Review and approve complaint investigation records in a timely manner.
Develop Product Analysis Guidelines and test methods to analyze complaints. Serve as a technical trainer to the Regional Investigation Center 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. Lead corrective and preventative action (CAPA) activity. Apply systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving systemic non-conformance.
Own and execute Non-Conformance Reports. 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. Assist local management team in reviewing process implementation and provide recommendation to resolve processing challenges, increase productivity and improve workflow. Support local process implementation and global continuous improvement initiatives by serving as a subject matter expert in the field of complaint processing on topics relating to physical device inspection, complaint investigation and data trending.
Job Qualifications Required: A four-year degree in a technical discipline (e. g. EE, ME, BME, Quality Assurance), or equivalent knowledge. Minimum of 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 Previous experience working with CAPAs, NCRs, and other quality management system functions. Available to travel to customer sites for product evaluation, ~10% Available to travel to the manufacturing sites for product training, ~5% #LI-Hybrid Why join Olympus? Here, people matter—our health, our happiness, and our lives. Competitive salaries, annual bonus and 401(k) with company match Comprehensive Medical, Dental, Visions coverage effective on start date 24/7 Employee Assistance Program Free virtual live and on-demand wellness classes Work-life balance supportive culture with hybrid and remote roles 12 Paid Holidays Educational Assistance Parental Leave and Adoption Assistance Volunteering and charitable donation match programs Diversity & Inclusion Programs including Colleague Affinity Networks On-Site Child Daycare, Café, Fitness Center US Only Limited locations We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.
Learn more about our benefit offerings at /careers/benefits-perks. The anticipated base pay range for this full-time position working at this location is $90,153.00 - $121,707.00 / 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. About us: Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
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 .
Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive. 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, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual 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)
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