Share this Job
Apply now »

Global Vice President Design Control - TSD

Req ID:  3337

Working Location: Nationwide 

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 Global Vice President – Design Control – TSD will oversee all Quality Activities in New Product Development for the Therapeutic Solutions Division (TSD). This person will be responsible for all Design Control activities in nine design centers around the world (Seattle, Brooklyn Park, St Louis, Westborough, Golden, Co, Hamburg, Berlin, Cardiff, and Or Akiva). They will execute the Olympus QMS and be directly responsible for the Design Control Quality Organization – including Design Control Engineering, Microbiology, Sterilization, Biocompatibility, Risk Management, Product Cyber, Sustaining Engineering, Security and the Human Factors Engineering. They will provide leadership, strategy, vision, oversight, training and mentoring to this organization for new product development and end to end product quality.

Job Duties

* Develops and executes vision and strategy for the end-to-end Product Design Assurance efforts.

 

* Mentors and leads the Design Assurance Quality Engineering staff supporting new product development and sustaining engineering projects across multiple sites.

 

* Mentors and leads the Microbiology, Sterilization and Biocompatibility staff supporting new product development, sustaining engineering projects and routine production across multiple sites.

 

* Mentors and leads the Human Factors/ Usability Team supporting new product development and sustaining engineering projects across multiple sites.

 

* Champion and subject matter expert for customer and patient focused end to end Risk Management.

 

* Supports complaint investigations, signal detection, product issue escalations and a closed-looped Post Market Surveillance process.

 

* Supports facility audits by outside agencies (i.e., FDA, ISO / MDSAP) point of contact and subject matter expert to demonstrate compliance to regulatory requirements and the Olympus Design Control System.

 

* Budget responsibility for the TSD Design Control Quality organization.

 

* Stakeholder and collaborator with senior management relating to project, process, business, and quality decisions.

 

* Other Quality Assurance responsibilities as assigned by Management.

Job Requirements

REQUIRED QUALIFICATIONS

* Minimum requirements are a Bachelor's degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree; Master's degree preferred.

 

* Minimum of 15 years of experience in quality management with at least 5-7 years of senior management experience and 5 years of new product development experience in a global position that is in a regulated environment in the MedTech industry.

 

* Other Considerations (travel/hours availability, etc.): Global role: The individual will be expected to schedule meetings that work for multiple time zones and well as 20 to 35% travel should be expected.

 

PREFERRED QUALIFICATIONS

* Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the MedTech industry e.g., ISO, QSR, GMP, GLP, GCP, HIPAA.

 

* Demonstrated knowledge of and experience in pre-market regulations including regulatory, risk management, and cyber security processes.

 

* Proven track record in a global execution of New Product Development delivering robust, customer, and patient focused products.

 

* Demonstrated expertise in the design, implementation and measurement of quality systems and metrics in the design control space.

 

* Proven track record to drive value and product differentiation through the design control team.

 

* Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.

 

* Strong technical skills related to product quality including Voice of Customer translation to design specifications, human factors, CTQ cascades, design characteristics, verification & validation, test method validation, process validation, inspection techniques and statistics.

 

* Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment. • Excellent written and oral communication and organizational, project management skills. 

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: Engineer, Quality Manager, VP, Executive, Engineering, Quality, Management

Apply now »