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Quality Engineer II

Req ID:  2568

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 System Quality System Engineer II will develop, maintain and improve the Quality System for Breinigsville (OAI) location to ensure it is compliant with domestic and international standards. To interface with users of the system to ensure the Quality System meets the business needs. Serve as Audit, CAPA and NCR coordinator to ensure timely execution to QMS activities in these systems. Execute supplier management activity as required by local QMS and maintain ASL. Provides site expertise in the application of Quality Sciences including statistics data analysis problem solving and the creation of system solutions.

Job Duties

* Ensures that a Quality System is established and implemented in accordance with US and International requirements and must report on the performance of the quality system to the Company's management as directed for review and as a basis for improvement of the quality system. 

 

* Provided site coordination of Audit, CAPA & NCP to the region. Serve a primary CAPA verification liasion. 

 

* Support and facilitate Internal and External Quality audit activity. 

 

* Perform OAI Supplier Audits and maintain qualification documentation as needed to maintain the ASL. 

 

* Provide guidance on change management of local QMS and aid in the development of applicable training requirements. 

 

* Support key Quality System and organizational initiatives and improvement activities (i.e. Transform Medical).

 

* Collaboration and approval of OEM SCAR activities. 

 

* Approve final inspection forms fo rincoming materials and review/approve Breinigsville (OAI) rework activity. 

 

* Generate submissions and maintain Drug Licensing for the region.

 

* Coordinate and support ship hold process for OSTA and OAI. 

 

* All other essential duties as directed. 

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelors degree or equivalent and 3+ years related experience and or training; or the equivalent combination of education and experience.

 

* Strong analytical and organizational skills are required. 

 

* Strong attention to detail and accuracy are required.

 

* A strong foundational understanding of a quality system and its components is required.

 

* Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD 93 42 ISO 13485 2003 and Canadian Medical Device requirements and the ability to educate and advise others on related subject matter.

 

* Experience training and/or mentoring others is required.

 

* Candidate must have the ability to read write and communicate effectively in English is required; this requirement includes clear understandable speech and demonstrated comprehension skills. 

 

* Other considerations: up to 20% travel; must be able to support Breinigsville business hours (8-5 EST).

 

PREFERRED QUALIFICATIONS:

 

* Excellent verbal and written communication skills.

 

* Ability to create and deliver training to all levels within the organization.

 

* Strong people skills ability to effectively interact at all levels within the corporation.

 

* The ability to collaborate and work in a cross-functional environment.

 

*  Must be able to demonstrate a working proficiency in operating a personal ocmputer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications. 

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 || 


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

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