- Acts as supplier quality engineering representative in new product development projects
- Performs Advanced Product Quality Planning (APQP) by applying the appropriate methods including early supplier involvement into development projects and assures that required process validations are sufficiently implemented
- Coordinates and ensures the external software qualification/validation process is effective
- Identifies gaps in suppliers' capabilities / technical project risks
- Makes decisions on acceptance or rejection of software product
- Develops validation process for software in collaboration with suppliers
- Responsible for SCAR process as part of the NC process
- Leads improvement projects at the supplier
- Acts as primary interface to supplier regarding software product related quality matters
- Analyzes product related supplier quality issues
- Supports facility audits by outside agencies (i.e., FDA, ISO/ MDSAP)
- Supports Supplier audits for new suppliers and ongoing surveillance audits for existing suppliers.
- Performs local supplier management such as supplier approval, Quality Agreement negotiation and supplier evaluation.
- Minimum requirements are a BA/BS degree or equivalent in a Computer Science, Life Science, Engineering, or Physical Science with an advanced technical degree.
- Minimum of 5-10 years in a related field
- Knowledge of industry software development standards such as IEC 62304 and/or IEC 82304
- Familiarity with cyber security standard ISO/IEC
- Experience with supplier audits for software controls
- Understanding of software validation processes
- Knowledge of embedded software in medical devices and purchased software as a product
- Very good knowledge of Quality tools and methods
- ISO 9001 I FDA I Medical technology background
- Basic project management skills
- Advanced English
- 20% travel should be expected.
- 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, Caf, Fitness Center**
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Senior Supplier Quality Engineer, Software - Westborough, United States - Olympus Corporation of the Americas
Description
Working Location: MASSACHUSETTS, WESTBOROUGH; CALIFORNIA, SAN JOSE; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEYWorkplace Flexibility: Hybrid
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for 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
The Senior Supplier Quality Engineer, Software is responsible for the product-related supplier quality within the supplier-provided software category. The Sr. SQE will be involved in New Product development, ensuring the suppliers meet Olympus requirements and industry standards. This role will be an integral part of the initial and ongoing auditing of suppliers for software controls.
Job Duties
Required:
Here, people matter-our health, our happiness, and our lives.
**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
The anticipated base pay range for this full-time position working at this location is $95, $129,148.00 / 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, 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 If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
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