PCI Pharma Services · 4 hours ago
Sr. Supplier Quality Engineer
Rockford, IL
Full-time
Onsite
Senior Level
$87K/yr - $98K/yr
5+ years expPCI Pharma Services is dedicated to creating life-changing therapies and making a global impact. The Sr. Supplier Quality Engineer will track data, manage improvement projects, and collaborate with cross-functional teams to enhance supplier performance and ensure compliance with quality standards.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Oversee the Component Variability Notification (CVN) process including primary point of contact for Operations/Maintenance/Quality when issues are identified
Responsible for internal root cause analysis of component related issues, working with component suppliers for remediation and path forward when needed, and providing timely feedback to internal teams
Manage Non-Conforming Material reports and process
Manage component specification templates, updating the templates to define technical aspects that will enable sustainability of continuous improvement initiatives, drive down scrap, and increase uptime
Responsible for working with internal teams to define specs/tolerances for components and holding discussions with suppliers related to newly defined specs/tolerances related to components and ensuring test method/equipment alignment between PCI and suppliers
Work closely with Accounting, Procurement, and Warehousing to ensure appropriate disposition of non-conforming product, credits received, and inventory adjustments within the ERP system
Develop and implement corrective and preventive actions as needed
Utilize statistical methods and Lean Six Sigma applications to generate and analyze data
Assist Quality Customer Focused Teams with supplier quality related events. Generate and manage supplier quality related metrics (prepare graphs and charts from various data sources)
Analyze supplier metrics for trends, identify root causes, and implement actions to mitigate negative trends
Meet with PCI management and supervisors to discuss likely root cause scenarios for component related issues
Visit and meet with suppliers to review process controls and inspection systems in place that may be leveraged to reduce workloads at PCI and communicating these findings back to management
Write/Revise SOP's/WP's and route in E-Doc system
Participate in new product introduction meetings including kickoff and technical definitions meetings and assist in FMEA activities as needed
May assist with supplier audits as needed or required
Responsible for the administration, implementation, and project management of assigned special projects, including using standardized methodology
Work closely with Operations and Procurement departments to partner on projects
Host or participate as Quality Engineering representative for Supplier Review Meetings and supplier investigations when needed
Participate in Customer and Regulatory audits. Participate in Supplier audits and visits for understanding of component manufacturing processes
This position may require overtime and/or weekend work
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager or Supervisor
Qualification
Required
Bachelor's Degree in a related field and/or 5-10 years related experience and/or training
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables
High Standard of Report Writing
Preferred
ASQ CQA certification
Ability to set and achieve challenging goals
Ability to demonstrate attention to detail
Ability to exhibit sound and accurate judgment
Ability to follow instructions and respond to management direction
Ability to identify and resolve problems in a timely manner
Ability to display excellent time management skills
Ability to adapt to changing work environments
Ability to work independently and/or as part of a team
Benefits
Paid time off
Health insurance coverage (including dental and vision)
A flexible spending account
A 401(k) plan
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase