Senior QA Associate, Supplier Quality

GENERAL PURPOSE

This role supports the implementation and continuous improvement of PBS’s Quality Management System (QMS) and is responsible for management of programs such as supplier qualification, supplier quality performance management, and supporting supplier audits. This role supports internal audits, customer audits, and regulatory affairs including regulatory related requests.
 

Responsibilities

Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
 

Support the QMS implementation, ensure suitability, and continuously improve the structure and processes. Manage and oversees all aspects of the Supplier Qualification process. Support GxP compliance and regulatory related requirements, external and internal audits, and customer and suppliers’ requests. Interface with QMS users to improve assigned QMS processes and procedures.
Primary Responsibilities

• Support the company’s efforts for CGMP qualification and ISO Certification.
• Supports aspects of the Supplier Qualification process including metrics and risk management documents.
• Supports the Supplier Quality surveillance plan and activities.
• Manage supplier qualification activities for low risk (low criticality) to medium risk (medium criticality) suppliers.
• Partners with Supply Chain for management and follow up of Supplier Corrective Actions Reports (SCARs) and implements identified improvements and actions if needed.
• Initiate, review, and approve SCARs.
• Escalate supplier quality issues to stakeholders.
• Manage, perform, and support supplier capability to meet product requirement specifications.
• Manage Supplier Change Notifications.
• Execute actions associated with Change Management and Corrective/Preventive Acton's (CAPA), including ownership of these records.
• Facilitates Root Cause Analysis and Corrective Action activities with Suppliers as a result of Audit, Compliance, or Product deficiencies.
• Member of the Supplier Review Board (SRB) team in providing input and data related to deployment of SQM strategy and monitoring of supplier continuous improvement.
• Responsible for supporting continuous improvement of SQM processes.
• Performs various administrative activities related to supplier quality information in the PBS Enterprise Resource Planning (ERP) system.
• Support Deviations and Customer Complaints where supplier-related deficiencies are involved.
• Support procedure creation/updates, training, and data trending/reporting for Supplier Quality Management.
• Supports the deployment of QMS processes and promotes on-going education of the QMS and regulatory requirements including Supplier Quality training for involved departments such as Engineering and Supply Chain.
• Supports the tracking & reporting for the quality programs, including development and monitoring metrics that support key performance indicators (KPIs) for the organization. Provides reports to management, as required. Provides and may execute suggested remediation activities.
• Identify opportunities for and participate in continuous improvement of the QMS program, which may include seeking feedback from stakeholders.
• Maintain a state of inspection readiness and participate in inspection preparation activities.
• Assist in the design and implementation of electronic quality management systems (eQMS) for Supplier Quality Management.
• This role is considered a QA function and may provide QA approvals where assigned.
• Assignments may vary based on business needs.

Minimum Qualifications

The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.
Minimum of 3 to 4+ years of supplier quality experience including working directly with suppliers.
3 to 4+ years of experience in a role for medical products in a regulated environment.
 

Knowledge/ Experience

• 3 to 4+ years of experience within a QMS that requires a high degree of supplier management, quality control, ideally GMP quality system, medical device (QSR/ISO13485), aerospace (AS 9100), ISO 9001, or other similar systems.
• 3 to 4+ of experience in a role for medical products in a regulated environment. e.g., medical device, single use medical or biopharma products, or similar field.
• Bachelor’s Degree – Engineering, Supply Chain Management, Biotechnology, Logistics or related field of study.

Skills/ Abilities Pertinent to This Position

• Working knowledge and experience with ERP enterprise resource planning software (e.g., GSS) and electronic quality management systems (e.g., Veeva).
• Technical writing and ability to write and understand investigation reports.
• Strong verbal communication and presentation skills.
• Ability to use statistical tools for decision-making processes, root cause analysis, and risk assessments.
• Ability to interface with external suppliers.