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Quality Systems Manager

Req ID:  3432

Working Location: MISSOURI, ST. LOUIS 

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 Quality Systems Manager assists in the development, implementation, and maintenance of the Quality Management System. The manager oversees engineers, supervisors and inspectors, ensuring that the quality system maintains compliance with domestic and international requirements. The candidate is responsible for multiple quality system processes, including but not limited to, document control, change management, complaint investigations, supplier qualification and maintenance, internal audits, and material and product inspections. The candidate works cross-functionally to ensure quality processes and principles are implemented across the organization.

Job Duties

* Provides Quality oversight/guidance for medical devices and quality systems.

 

* Develop, implement, maintain and improve quality management system processes in accordance with applicable standards and regulations (ISO 13485, FDA QSR, EU MDR, etc).

 

* Ability to combine input from multiple sources to provide solutions to teams and manufacturing facility regarding quality, including product development compliance.

 

* Supports activities related to complaints, including Medical Device Report investigations as needed. (MDRs).

 

* Manage corrective and preventative action (CAPA) related activities.

 

* Manage internal quality system audits to ensure compliance to applicable standards and regulations (ISO 13485, FDA QSR, EU MDR, etc).

 

* Assist during FDA inspections, ISO audits, etc. to provide objective evidence.

 

* Lead audit readiness activities and facilitate audit management (back room / front room process)

 

* Manage the complaint investigation process and related activities.

 

* Manage document control activities.

 

* Manage activities related to product acceptance.

 

* Communicates issues or developments identified during quality assurance activities and provides recommended improvements.

 

* Assists in the change control process, and provides guidance to product development teams throughout the product development process to ensure compliance to the required deliverables, resulting in the development of safe and effective medical devices. · Assists in the evaluation and qualification of suppliers, manufacturers and vendors

 

* Other Essential Duties as directed.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor’s degree is required.

 

* Minimum of 8 years progressively responsible experience operating as a Quality representative in a highly regulated manufacturing environment or equivalent experience required.

 

* Travel to other Company facilities, vendors, etc. may be required; up to 10% 

 

PREFERRED QUALIFICATIONS:

 

* Minimum of 3 years in Quality Management in an FDA regulated environment preferred

 

* ASQ Quality Engineer or Auditor certification preferred, but not mandatory

 

* Knowledge of ISO 13485, 21 CFR Part 820, 93/42/EEC Medical Devices Directive, EU Regulation 2017/745, SOR 98/282, Canadian Medical Device Regulations, 21 CFR Part 11, ISO 14971, ISO 11135, ISO 10993-1, ISO 11607 and other medical device industry US and international standards.

 

* Ensure compliance to standards, regulations and Company procedures.

 

* Ability to identify issues, determine root cause, and implement solutions.

 

* Identify and facilitate process and SOP improvements within the Quality System, embracing a culture of continuous improvement.

 

* Experience with risk analysis and reliability engineering techniques.

 

* Proficient in product & process development concepts, including change control, design verification and validation

 

* Other projects and duties as necessary and assigned.

 

 

* This position is eligible for a sign-on bonus.

 

* Relocation benefits may be available for this position.

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


Nearest Major Market: St Louis

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

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