Job Description

Working Location:  MASSACHUSETTS, WESTBOROUGH  

Workplace Flexibility:  Onsite

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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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.

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Our five Core Values empower us to achieve Our Purpose: 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

**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

The Director of Supplier Quality provides strategic leadership and focus across supplier quality management activities for OSTA. Works with external manufacturers and suppliers providing finished products services components and sub-assemblies to ensure compliance with company policies specifications procedures and medical device regulations. The Director of Supplier Quality will partner with Manufacturing Engineering Operations R&D Supply Chain leaders and other departments to continuously improve products and processes that meet customer and patient requirements.

Job Duties

• Mentors and leads the Supplier Quality Organization.
• Champions the supplier quality management program for legacy products and support of new products under development per OSTA new product development (NPD) process.
• Develop the strategy and execute on a proactive risk-based Supplier Management Governance Process that reviews Supplier Performance and trending for items such as NC's CAPA's SCAR's Audit Results etc.
• Lead the evaluation of new or transferred suppliers and/or changes to the Approved Supplier List (ASL) and the Supplier Change Notification (SCNs) process.
• Oversee supplier process management i.e. risk management quality assurance agreements control plans supplier assessments / audits submitted validations process failure modes and effects analysis (pFMEA) CtQ cascades and supplier inspection plan / method evaluations.
• Utilize effective and efficient Quality Engineering techniques such as root cause identification risk analysis statistical data analysis process capability analysis design of experiments measurement system analysis control plans and development of sampling plans throughout the product lifecycle.
• Author collaborates and approve quality system documentation via Agile PLM.
• Perform other duties as assigned by management.

Job Qualifications

Required:

• Bachelor's Degree in Engineering required.
• Minimum 10 years of experience in Supplier Quality or Quality Engineering in the Medical Device Industry.
• Experience leading and managing direct reports is required.
• Proven ability to lead champion change develop and execute strategies to meet goals.
• Proficient with DMAIC / Black Belt / Six Sigma type tools to analyze drive root cause and solve problems.
• Proficient with statistics sampling strategies design of experiments process capability including statistical software tools such as Minitab.
• Proficient with process trouble shooting in the areas of injection and insert molding extrusion stamping wire EDM and CNC machining.
• Understanding of the design development and tolerancing of complex systems. 
• Strong knowledge of Risk Management practices.
• Corrective and Preventative Actions and regulatory requirements such as FDA QSRs ISO 13485 & ISO 14971 are required.
• Strong written and oral communication skills are required. 
• Travel Required – Up to 40%

Preferred:

• Master's Degree preferred.
• Working knowledge of GD&T is a plus.
• Proficient in most common PC based applications (Word Excel PowerPoint Project & Visio) including Agile PLM. ISO 13485 Lead Auditor certification is 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

• 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?

The anticipated base pay range for this full-time position working at this location is $147,763.00 - $206,869.00 / 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 .

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) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)  

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