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Supplier Quality Director

Req ID:  2612

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

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 Requirements

REQUIRED QUALIFICATIONS: 

 

Bachelor's Degree in Engineering required. Master's Degree preferred.

 

* Minimum of 10 years of experience in Supplier Quality or Quality Engineering in the Medical Device Industry.

 

* Experience leading and managing direct reports is required.

 

* 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 QUALIFICATIONS: 

 

* 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.

 

* 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.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ 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 overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

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) || Massachusetts (US-MA) || Westborough || 


Nearest Major Market: Worcester

Job Segment: Manager, Engineer, Quality Manager, CAPA, Management, Quality, Engineering

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