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Director of Quality

Req ID:  4151

Working Location: Missouri, St. Louis; CALIFORNIA, SAN JOSE; COLORADO, GOLDEN; FLORIDA, MIAMI; MASSACHUSETTS, LITTLETON; MASSACHUSETTS, SOUTHBOROUGH; MASSACHUSETTS, WALTHAM; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY; TENNESSEE, BARTLETT 

 

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

Provides strategic leadership at the OSTA site and directs the execution of the Quality System to ensure compliance is maintained with regulatory requirements along with the business strategy of the company. Serves as the Quality Leader providing training and mentoring to the organization in quality matters supports new product development procurement manufacturing returns and servicing of products produced at the location. Is the Management Representative for location. Provides guidance and expertise across OSTA in various quality initiatives and serves as delegate for the Executive Director of OPS Quality. Leads OSTA wide quality projects.

Job Duties

* Provide leadership and direct projects for global RA/QAinitiatives.

 

* Directs and serves as subject matter expert on project teams toward understanding customer requirements regulatory requirements and technical capabilities of the system tool to be deployed.

 

* Develops implements monitors and improves a standardized Quality Management reporting system to assess and improve the quality system performance and ensures awareness of customer requirements throughout the organization. Set strategies for corporate quality improvement projects andstandardization. Collaborates with business users internal technology teams across Olympus and vendors to establish and prioritize business and technology requirements.

 

* Reviews assesses and develops business processes focusing on the effective use of resources both people and technology in the execution of the business process.

 

* Analyses the feasibility of and develops requirements for new systems and enhancements to existing systems; from a business and technology perspective to ensure the system design fits the needs of users.

 

* Translates business requirements into system deliverables that are understandable to the end-users. Directs change management to facilitate effective deployment of business systems. Work with and manage complex workflows as they pertain to business process.

 

* Creates documentation supporting business functions and processes(i.e. constructs workflow charts and diagrams; studying system capabilities; writing specifications; design documentation).

 

* Conducts change impact analysis to assess the potential implications of changes to documents functions and requirements.

 

* Writes detailed universally understood procedures for end users.

 

* Assists in developing overall change management strategy for projects developed for deployment. Directs user acceptance testing and validation testing of systems to be deployed.

 

* Assists in the development of validation documentation (i.e. IQOQ PQ and UAT).Directs training guidance and support for end users.

 

* Develops training materials and conduct training sessions with business users to improve adoption and efficient use of all systems. Defines project requirements by identifying project milestones, phases and elements.

 

* Monitors project progress communicating project status to the Executive Director and team responsible for the project identifying and mitigating potential risks to project success and tracking all project issues and managing their resolution. Directs project related tasks and teams.

 

* Provides work direction to one or more technical or business team members.

 

* Administrates and or facilitates working meetings for teams of primary stakeholders involved in process definition. Directs organizes and conducts project management reviews with Steering Committee and Olympus Stakeholders to evaluate progress and actions in the development of the system.

 

* All other essential related duties as required

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor’s degree or equivalent; and ten plus years related experience and preferable in medical device industry.

 

* Requires background and familiarity with U.S. FDA QSR requirements including MDD 93 42 ISO 13485 2003 and Canadian Medical Device requirements.

 

* Travel up to 50% of the time.

 

PREFERRED QUALIFICATIONS:

 

* ASQ certifications in one or more of the following areas is preferred but not required: ASQ Certified Manager of Quality Organizational Excellence (CMQ QE) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).

 

* Working knowledge of problem-solving skills good statistical and analytical skills.

 

* Proven success in driving cultural change.

 

* Proven Management and leadership skills; ability to lead and manage cross functional teams.

 

* Proficient in the use of Information Technology.

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 requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

 

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) || Missouri (US-MO) || St. Louis || 


Nearest Major Market: St Louis

Job Segment: Manager, Quality Manager, QA, Quality Assurance, Management, Quality, Technology

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