Quality Engineering Manager

Req ID: 9071

Working Location: CALIFORNIA, SAN JOSE

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.

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

Oversee management responsibilities for Quality Engineers. Responsibilities to include, leadership and guidance; employee planning, and assigning work direction. May serve as a site Management Representative, as delegated. Manage the execution of activities to ensure compliance with the OSTA and local Quality Systems, Regulatory requirements, and the business strategy of the company. Leads Quality Projects and CAPAs. Supports and leads Change Orders, as needed. This position reports into the Director of Quality, San Jose Operations.

Job Duties

Promotes awareness and compliance to all relevant Quality and Regulatory requirements across the site. Ensures that adequate equipment and supplies are provided, where needed, And for appraising job results, including Quality related Productivity and Efficiency.
Supports operations to assist the efficient processing of Change Orders and processing of medical devices through their processes.
Applies the requirements of the Quality System to processes, products or services for the site.
Ensures that inspections occur effectively and efficiently.
Manages calibration for equipment used by the site (overall but including quality, timeliness, and cost).
Ensures that Preventive Maintenance activities are performed for Quality equipment.
Manages audit preparedness, including internal audits and third-party audits.
Responsible for the compliance of the NCR process (including the timeliness and completeness of actions taken) Leads MRB to ensure proper and timely disposition of non-conforming product (NCRs)
Ensures that metrics are provided for management review (CAPA Board, formal Quality Systems
Management Reviews, etc.).
Communicates significant issues to site senior management and corporate management and ensures that plans for correction are developed.
Take actions to achieve and maintain goals related to audit results (no Majors, etc.).

Job Qualifications

Required:

A 4-year degree in Engineering or other related science required.
Minimum of five (5) years experience in the Medical Device industry where the individual was responsible for ensuring either improved product quality, improved Quality compliance, or both with responsibility for others' compliance, timeliness, and/or efficiencies.
Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, and ISO 13485.
Travel up to 10% of the time.
All other essential related duties as required.

Preferred:

Strong working knowledge of problem solving skills.
Excellent verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management.

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
Diversity Equity & Inclusion Initiatives including 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 $99,824.00 - $134,763.00 / 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.

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, 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.

Applicants with Disabilities:

As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at 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).

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: Quality Engineer, Quality Manager, Engineering Manager, Medical Device Engineer, Engineering, Quality

Apply now »