QA Engineer I

Req ID: 9730

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.

Job Description

The Quality Assurance Engineer I is responsible for providing Quality Engineering input to support Production, Operations and Engineering activities. Maintains and follows Quality Engineering methodologies, systems, and practices which meet Olympus, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility and communication on Quality initiatives to support departmental, functional, site, divisional and corporate Quality goals and priorities. When needed, works with Olympus Toyko representatives/liaisons to resolve Quality related issues.

Job Duties

Provide Quality Engineering support on projects to implement new product introduction or alternate repair activities. Train Technicians, Supervisors and other employees on the use of new products or processes.
Perform packaging and equipment validations and other verifications/validations to support new product or new repair introductions.
Provide technical guidance to the Change Control Board; educate members on technical issues associated with assigned projects.
Support continues improvement measures by providing technical information and reviewing processes as they are revised.
Address or initiate Engineering Change Orders (COs) in a timely manner to maintain project schedules and/or achieve acceptable levels of compliance.
Supports problem solving activities to resolve Quality issues.
Support and/or drive corrections and corrective actions to resolve non-conformances (DMNs, NCRs, CAPAs and ADT) with minimal guidance.
Communicate significant issues or developments identified during Quality assurance activities and support process improvements identified by cross-functional teams (CFTs) and management.
Analyze Production and Complaint data and identify significant trends.
Manage calibration and metrology activities needed to support Production. Work with the calibration bendor to develop a routine calibration schedule. Coordinate emergency calibrations and complete Out of Tolerance reports as needed.
Support the Quality Management System (QMS) by performing periodic product, process, and internal audits. Support and participate in external audits as needed.
Work with Operations to resolve material issues.
Work directly with the OEM to resolve Quality problems identified through complaint investigations and/or other sources of Quality data.
Perform all other related duties as assigned.

Job Qualifications

Required:

Bachelor's Degree in Engineering or Scientific Discipline (or equivalent) with 0-2 years experience of Engineering or related experience.
Working knowledge of metrology and typical metrology instruments including calipers, micrometers, snap gages, etc.
Effective written and verbal communication skills.
Able to communicate clearly.
Must be able to work effectively cross-functionally.
Basic understanding of mathematical concepts such as probability and statistical inference as well as perform basic mathematical calculations.
Ability to organize, prioritize and schedule work assignments with supervision.
Ability to solve practical problems.
Ability to complete project tasks and assignments in a timely manner.
Proficient in Microsoft Office.

Preferred:

Working knowledge of Datasweep, Adwatch, SAP and JDE preferred.
Working knowledge of AutoCAD and/or SolidWorks preferred.
Basic understanding of ISO 13485 and FDA Regulations preferred.
Basic understanding of 5S and other forms of waste in the Production environment preferred.
Basic understanding of good manufacturing practices 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 benefit and incentives.

The anticipated base pay range for this full-time position working at this location is $76,874.00 - $103,780.00 / 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, QA Engineer, Manufacturing Engineer, Quality Engineer, Technology, Quality, Engineering

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