Sr. Supplier Quality Engineer

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

This position tracks data, identifies improvement projects, and manages cross functional implementation to improve performance of key components and suppliers and helps drive project success to provide PCI a competitive advantage in long-term quality customer and supplier management and maintaining GMP compliance and system improvement. This individual will also partner closely with Quality Inspectors, Production, Maintenance, Engineering, and Procurement to provide resolution to quality issues regarding components, non-conformances related to any related processes and recommend solutions based on SOP / cGMP requirements. This position may have 1-3 individual reporting.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned.

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.                                                                                                                                                            

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.