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Process Engineer, Market Quality

Req ID:  2294

Working Location: PENNSYLVANIA, CENTER VALLEY; CALIFORNIA, SAN JOSE; MASSACHUSETTS, SOUTHBOROUGH; MINNESOTA, BROOKLYN PARK; 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

The Market Quality Process Engineer is responsible for finding ways to prevent waste and inefficiency in process by designing efficient systems that integrate and assist in the prioritization and scheduling of workloads, identifying process improvements and ensuring teams are managing daily activities most efficiently. The engineer also designs processes to coordinate workload planning to minimize complaint processing issues and ensure complaint records are closed in a timely manner with the highest of quality standards. The engineer assists the investigation of complaints involving Olympus devices, working closely with associated business partners to lead product complaint investigations and provide inputs to product quality improvements. The engineer periodically reports to management about quality discrepancies identified as part of the complaint process and helps identify process improvement opportunities based on data collection, trend analysis and reporting activities. The engineer will work independently, taking initiative to investigate and resolve product complaint issues and will take on a leadership role in departmental projects and initiatives as assigned.

Job Duties

* Reviews process information to understand methods and activities in the complaints and surveillance organization. This includes, but is not limited to, schedules, process flows and workflows.


* Designs systems to minimize and resolve processing issues and increase productivity.


* Plans daily workload management to ensure all records and samples are processed in a timely manner.


* Develops processes to ensure productivity and efficiencies.


* Designs, develops and maintains processing and oversight practices to maximize effectiveness, efficiency and space.


* Ensures the organization complies with all standards for safety, quality, and compliance.


* Review complaint files to ensure files meet all defined requirements prior to closure.


* Initiates and leads special departmental projects as assigned by Market Quality management.


* Assists management in identifying process improvements in routine tasks and assist with implementing process improvements or changes.


* Supports continuous improvement measures by providing technical information and reviewing processes as they revised.


* Communicates significant issues or developments identified during market quality activities and provide recommended process improvements to cross-functional teams (CFTs) and management.


* Trains new Market Quality Engineers on the established processes.


* Provides trending analysis and recommends corrective or preventive actions.


* Works in a support role as needed on less complex projects.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* A four-year degree in a technical discipline. (e.g. Mechanical Engineer, BioMedical Engineer, Quality Assurance, Manufacturing Engineer, Industrial Engineer)

 

* Minimum 5 years of experience dealing with regulatory or quality assurance issues in the medical device or pharmaceuticals industries.

 

* Specific experience in complaint-handling activities.

 

* Knowledge of Quality System Requirements (21 CFR 820 & 803) is required.

 

* Experience in planning, coordinating, and managing large throughput operations.

 

* Available for late meetings with overseas colleagues

 

* Ability to travel to other sites both domestically and internationally.

 

PREFERRED QUALIFICATIONS:

 

* In-depth knowledge of planning, priorization, and scheduling tools
 

* Understanding of Investigations and Root Cause Analysis
 

* Indirect leadership skills and the ability to oversee multiple projects simultaneously
 

* Effective written and verbal communication skills.
 

* Understanding of the criticality of aligning target timeline and driving process improvements.

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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