- Massachusetts, Westborough
- California, San Jose
- Minnesota, Brooklyn Park
- Pennsylvania, Center Valley
- Serve as the supplier quality engineering representative in new product development initiatives
- Execute Advanced Product Quality Planning (APQP), ensuring early supplier involvement in development projects and validating necessary processes
- Coordinate and enhance the effectiveness of external software qualification/validation processes
- Identify deficiencies in suppliers' capabilities and technical risks in projects
- Make critical decisions regarding acceptance or rejection of software products
- Develop validation procedures for software with supplier collaboration
- Manage the SCAR process within the NC process
- Lead improvement endeavors at the supplier organization
- Serve as the primary point of contact for suppliers on software product quality matters
- Analyze product-related supplier quality challenges
- Support facility audits conducted by external entities (e.g., FDA, ISO/MDSAP)
- Conduct Supplier audits for new and existing suppliers
- Perform local supplier management activities including approval, negotiation of Quality Agreements, and evaluation.
- Minimum of a BA/BS degree or equivalent in Computer Science, Life Science, Engineering, or Physical Science with an advanced technical qualification
- 5-10 years of experience in a related field
- Familiarity with industry software development standards like IEC 62304 and/or IEC 82304
- Knowledge of cyber security standard ISO/IEC
- Experience in conducting supplier audits for software controls
- Understanding of software validation processes
- Familiarity with embedded software in medical devices and purchased software
- Solid grasp of Quality tools and methods
- Background in ISO 9001, FDA, Medical Technology
- Basic project management capabilities
- Proficiency in Advanced English
- Expected 20% travel
- Competitive remuneration, annual bonus, and 401(k) with matching
- Comprehensive Medical, Dental, Vision coverage from day one
- Round-the-clock Employee Assistance Program
- Access to free virtual live and on-demand wellness sessions
- Culture supportive of work-life balance with hybrid and remote opportunities
- 12 Paid Holidays
- Education Support
- Parental Leave and Aid for Adoption
- Programs for Volunteering and matching charitable contributions
- Diversity & Inclusion Initiatives including Colleague Affinity Networks
- On-Site Childcare, Cafeteria, Fitness Center**
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Senior Supplier Quality Engineer, Software - Westborough, United States - Olympus Corporation of the Americas
Description
Working Locations:Workplace Flexibility: Hybrid
Looking to join a remarkable company that prioritizes well-being and health, yours included? Let's collaborate to enhance lives.
Olympus, an esteemed medical technology firm, has been dedicated to enhancing lives for a century.
Our Mission is to enrich lives by promoting health, safety, and fulfillment.
Our Guiding Principles resonate in all our actions: Integrity - Empathy - Agility - Unity - Long-Term View
We remain Authentic to Reality as we fulfill our mission and adhere to our core values.
Role Overview
The Senior Supplier Quality Engineer, Software pertains to product-related supplier quality within the category of supplier-provided software. This individual will play a key role in New Product development, ensuring that suppliers meet Olympus' standards and industry norms. They will be crucial in initially auditing suppliers for software controls and conducting ongoing assessments.
Responsibilities
Mandatory:
Here, individuals take precedence – our well-being, contentment, and lives.
**Limited availability
We prioritize your health and financial stability, offering resources to ensure you are vital, confident, and prepared for any challenge life brings. Discover more about our benefits on our website.
The expected salary range for this full-time role at this location is $95,000 - $129,148 annually, with potential for yearly bonuses (subject to eligibility and other conditions). Various factors such as experience, location, education, and certifications are considered in determining actual compensation.
About Olympus:
Our Medical division utilizes innovative medical technology, therapeutic interventions, and precision manufacturing to enable healthcare providers to perform diagnostic, therapeutic, and minimally invasive procedures that enhance clinical outcomes, reduce costs, and improve patients' quality of life and safety.
With headquarters in Tokyo, Japan, Olympus has a global team of over 31,000 employees across nearly 40 countries. Olympus Corporation of the Americas, a wholly-owned subsidiary, is based in Center Valley, Pennsylvania, USA, employing over 5,200 individuals across North and South America.
Olympus is committed to establishing an inclusive, diverse, and authentic workplace
We value diversity in perspectives, backgrounds, and lifestyles, emphasizing inclusion, empathy, and unity. Our aim is to nurture a workplace where all employees can contribute and flourish.
Let's unlock your potential, together.
It is Olympus' policy to provide equal opportunities for employment and advancement to all individuals without regard to various factors listed in our non-discrimination policy.
Applicants with Disabilities: As a Federal Contractor, Olympus ensures that our hiring process is accessible to everyone. If you require assistance due to a disability during the application or hiring process, please reach out to Olympus. If emailing is not feasible due to your disability, you can contact our HR Compliance Manager at the provided number.
Posting Notes: United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)
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