Change Coordinator

Philips · Pittsburgh, PA

Company

Philips

Location

Pittsburgh, PA

Type

Full Time

Job Description

Job Title

Change Coordinator

Job Description

Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.

Your role:

ECR/ECO Management:

  • Support the creation of FDA compliant ECO packages for all changes of varying complexity including new product introductions utilizing Configuration Management principles
  • Work in cross-functional ECO related activities in order to meet agreed upon deadlines
  • Identify and assist in resolution of roadblocks preventing release of change notices
  • Determine appropriate part numbers/BOM Structures prior to release (assist in BOM review activities)
  • Support Pilot Run activities
  • Support change notices in SAP (releasing parts BOMs and production documents)
  • Ability to understand need and use for different BOM set ups (example: active, engineering, alternates)
  • Ability to review ECR / ECO hierarchy / content and understand requirements and use
  • Create and maintain lot tracking
  • Ability to manage Electronic Device History Record activities, as needed
  • Provide guidance in trouble-shooting and driving resolution of ECR/ECO Management issues

Material Master Management

  • Create and change material masters as required
  • Extend part numbers into SAP to support multiple manufacturing facilities and engineering change activities
  • Understand required settings to obsolete parts/ Bill of Materials (BOMs)/ documents (including material implications)
  • Provide guidance in trouble-shooting and driving resolution of Material Master issues

Document Management

  • Review and approve documents for completeness and format accuracy prior to release
  • Understand document signature strategies
  • Complete document linkage at appropriate time
  • Ability to decipher information from generated reports
  • Review and approve Quality System Documents
  • Ability to retrieve historical information from current and legacy systems
  • Provide guidance in trouble-shooting and driving resolution of Document Management issues

Training

  • Guide and assist peers in job function areas as needed
  • Facilitate training internal and external to the PLDM Department
  • Contribute to the development of necessary training materials

Project Management

  • Support ECO activities as described above

You're the right fit if:

  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
  • Associate Degree or minimum of 3 years of similar work experience working in disciplined regulated industry and in the application of automated technology, particularly 21 CFR, ISO 13485, GAMP 5.
  • Proficient in Microsoft Office applications (Excel, Word, PowerPoint).
  • Proficient in SAP or equivalent. Knowledge of Configuration Management principles.
  • Familiar with process management methodologies and practices.
  • Excellent verbal communication, interpersonal, and technical writing skills; ability to prioritize and manage multiple simultaneous programs/projects.
  • Strong attention to detail is critical.
  • Ability to travel up to 25%.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

  • Learn more about our business.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Read more about our employee benefits.

If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details

The pay range for this position is $52,000 to $97,000 annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

All United States-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation. *Montana employees, learn more here.

#LI-PHI

#LI-HYBRID

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

Date Posted

06/30/2023

Views

3

Back to Job Listings Add To Job List Company Profile View Company Reviews
Neutral
Subjectivity Score: 0.7