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Quality Manager

Req ID:  3385

Working Location: PENNSYLVANIA, CENTER VALLEY 

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 Manager is responsible for managing the activities in support of the current and future Quality Management System at Olympus OAI.

The Quality Manager champions, develops and promotes quality activities to meet regulatory and quality requirements while supporting business goals and improving customer satisfaction. The Quality Manager is accountable for developing and executing solutions relating to quality and ensuring the Quality Management System is implemented and maintained effectively in the organization. The Quality Manager is the Management Representative for the assigned location and works cross-functionally to ensure quality processes and principles are implemented across the organization.

Job Duties

* Serves as the Management Representative for the location.

 

* Manages facility audits by outside agencies and internal Olympus compliance group to demonstrate compliance to regulatory requirements and Quality System.

 

* Ensures audits conducted that result in deficiencies are corrected per policy. Ensures Management Review is conducted per policy.

 

* Champion the development, implementation and continuous improvement of a Quality Management System to meet applicable standards and regulations and/or harmonize with global Olympus Quality Systems.

 

* Ensure the Quality Management System is effectively being maintained in the organization. Develop and revise Policies, SOP and WI as needed.

 

* Manage and oversee processes relating to product quality throughout product lifecycle.

 

* Manage and champion quality systems and tools, such as CAPA, Non- Conformance Reporting, Audit etc. and related activities.

 

* Manage change control process and document control activities.

 

* Manage activities related to product acceptance.

 

* Identify and coordinate training programs on the Company’s quality system(s) across all departments.

 

* Develop and execute strategies for addressing quality issues.

 

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

 

* Assists in the evaluation and qualification of suppliers, manufacturers and vendors.

 

* Oversee the maintenance and control of quality documents, business documents, labelling and training material.

 

* Monitor key performance indicators and prepare progress reports for Quality Review meetings and for senior management.

 

* Perform special assignments as directed

Job Requirements

REQUIRED QUALIFICATIONS

 

* Bachelor’s degree in engineering or technical discipline.

 

* 5+ years of experience of improvement and/or maintaining quality management system within Medical Device or regulated industry.

 

* Demonstrated knowledge of Quality (Audit, Change Control, NC, CAPA, Deviations, etc) is required.

 

*  Availability to take evening and early morning teleconferences.

 

* Experience with quality system development, implementation and maintenance.

 

* Ability to manage multiple projects, prioritize and meet competing deadlines. 

 

PREFERRED QUALIFICATIONS

 

* Demonstrated knowledge of FDA Quality System Regulations and ISO13485 preferred.

 

* Strong analytical, organizational and oral/written communication skills required.

 

* Self-motivated and able to work independently in a multi-task environment.

 

* Working knowledge of MS Office applications and ERP systems.

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) || Pennsylvania (US-PA) || Center Valley || 


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