Quality Engineer II

Olympus America, Inc.; San Jose (CA); On-site; USD 86,000 - 117,000; Full time

Benefits offered by this job

Competitive salary+annual bonus

401(k) with company match

Employee assistance program

Paid vacation and holidays

On-site daycare/cafe/gym

Job summary

Olympus America, Inc. seeks a Quality Engineer II to support Supply Chain with quality improvements, CAPAs, audits, and engineering activities. You will develop procedures, manage quality disposition, and lead CAPA projects while collaborating across functions and with international teams.

The role requires 3+ years in engineering and strong communication, with knowledge of ISO 13485 and FDA regulations. Olympus offers competitive pay, bonuses, PTO, and comprehensive benefits, with on-site

Qualifications

• Bachelor’s Degree in Engineering or a scientific discipline or more than three years of engineering experience.
• Minimum 3 years of engineering experience and strong written and verbal communication skills.
• Ability to communicate clearly across all levels of the organization and work cross-functionally.
• Experience guiding engineering/technical teams and handling statistics or probability concepts.
• Familiar with ISO 13485 and FDA Regulations; 5S/waste elimination knowledge is a plus.
• Proficiency with MS Office; SAP/BI tools preferred.

Responsibilities

• Develop and establish procedures meeting customer and regulatory requirements.
• Drive improvements for supply chain documented requirements and product disposition.
• Review and approve change controls as site Quality lead for Supply Chain.
• Ensure incoming goods inspections have clear specs and accessible documentation.
• Handle NCRs and MRB processes with cross-functional approvals.
• Lead CAPA activities related to Supply Chain functions.
• Recommend Field Service actions based on complaints and training needs.

Skills

Communication

Cross-functional work

Problem solving

Project leadership

Maths/Statistics

Prioritization

ISO 13485 knowledge

Education

Bachelor’s Degree in Engineering or Scientific Discipline

ASQ certification (preferred)

Tools

MS Office

MS Excel

MS Access

SAP

Minitab

SAP Business Objects

Job description

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 ofpatient 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.

The Quality Engineer II is responsible for providing Quality Engineering input to support Supply Chain with improvements, projects(including CAPAs and audit responses), and Engineering activities.

Further develops or establishes documented procedures which meet Olympus customer and regulatory requirements.

Serves as the site Quality representative within Supply Chain to improve awareness visibility and communication on Quality initiatives. This position supports departmental functional site divisional and corporate Quality goals and priorities. When needed, works with Olympus Tokyo representatives/liaisons to resolve Quality related issues. Responsible for quality related inventory management and disposition of quality hold material. Shares complaint and repair data to alert Field Serviceand Asset Management to where additional training/assistance may be required.

Job Duties

• Develop and establish documented procedures which meet Olympus customer and regulatory requirements and align well with other related processes and systems (e.g. WMI-Data sweep system interactions and associated process documentation).
• Check and drive improvements for continued adherence to Supply Chain documented requirements.
• Review and approve change control activities as the site Quality lead for Supply Chain.
• Ensure the inspection of incoming goods has clear specifications and that the documentation of incoming inspections is maintained and easily accessible when needed.
• Handle Supply Chain NCRs, with clear explanation of product disposition with approvals from Quality and Finance (when applicable). Manage the MRB process.
• Support or Lead CAPA activities related to Supply Chain functions whether direct or indirect.
• Recommends additional Field Service or Endoscopy Support Specialist activity where complaints show a need for action, support, training.

Job Qualifications

Required:

• Bachelor’s Degree in Engineering or Scientific Discipline or more than three (3) years of Engineering experience.
• Minimum of 3 years of expeerience.
• Must have strong written and verbal communication skills.
• Must be able to communicate clearly and present information concepts and ideas across all levels of the organization.
• Must have strong interpersonal skills and be able to work effectively cross-functionally.
• Provides project direction for engineering and technical teams.
• Ability to work with mathematical concepts such as probability and statistics.
• Ability to organize prioritize and schedule work assignments with some supervision.
• Ability to solve practical problems.
• Ability to work on multiple project tasks and assignments efficiently.
• Basic understanding of 5S and other forms of waste elimination in the Production environment.
• Working knowledge of ISO 13485 and FDA Regulations.
• Proficient in Microsoft Office.

Preferred:

• ASQ certification preferred.
• Ability to program in MS Excel MS Access SAP Business Objects and/or other Database tools preferred.
• SAP preferred.
• Working Knowledge of Minitab Software preferred.

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

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

The anticipated base pay range for this full-time position in this location is$86,465.00-$116,728.00/ year, plus potential for annual bonus(subject toplan eligibility andother 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 [e-mail]. 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.