Lead Quality Assurance Specialist
The Lead Post-Market Quality Specialist leverages Voice of Customer (VOC) to identify trends and determine appropriate escalation pathways in support of product sustainment activities. The role collaborates with Marketing, Sales, Customer Service, Operations, and Quality to monitor product performance, drives structured investigations in response to adverse events and trends, performs risk assessments to determine customer impact, and determines resolution through corrective/preventive actions when necessary. They are responsible for championing continuous improvement methodologies to advance product performance and ultimately improve the customer experience.
Key responsibilities include:
- 1.Develop a robust Post-Market Surveillance program, including data and processes needed to perform product performance trending/reporting, product/process investigations, risk assessments, and regulatory escalations.
- 2. Champion structured root cause analysis methods to drive product and process investigations while collaborating with key stakeholders.
- 3. Perform risk assessments to determine appropriate escalation pathways for product issues. Use risk to determine appropriate corrective and/or preventive actions, as needed.
- 4. Collaborate with commercial teams on customer responses and continuously educate customers on product performance expectations.
- 5. Leverage VOC to establish feedback loops in the organization which champion continuous improvement to enhance product and/or process performance. Provide lessons learned to New Product Development and Introduction (NPDI) teams to build Quality into products and/or processes based on market performance.
- 6. Comply with in-house and/or external specifications and standards (i.e., GLP, GMP, ISO)
- 7. Perform and/or support internal and external audits.
Responsibilities:
- Support the organization to apply relevant quality standards and establish appropriate quality assurance processes to ensure compliance to those standards. Evaluate relevant changes to industry standards and practices to improve the organization’s quality assurance systems.
- Evaluate internal controls, communications, risk management and maintenance of documentation, such as Standard Operating Procedures (SOPs), to assess compliance with internal and external safety, quality, and regulatory standards.
- Provide support in the management of controlled documents to include writing, formatting, uploading, maintenance, and document changes, while also maintaining physical and archived documents using industry standard document control, change control practices and information technology systems. Assist with determining requirements for records retention, storage and disposal for business activities governed by the quality assurance systems.
- Prepare, maintain, analyze, and present metrics related to quality assurance activities for management review. Support management in evaluating organizational performance against quality goals and assist in developing performance improvement plans. Assist with the implementation of any resultant action items.
Education and Experience:
- Bachelor's degree in a science or engineering field and 8 or more years’ experience, including 0-2 years' supervisory experience or equivalent experience.
- 5 or more years’ experience in Quality Assurance.
- Knowledge of quality management systems in a highly regulated environment operating under one of the following: ISO13485 or cGMP.
Travel Requirements:
- Travel is required (estimated 10%)
Other Duties:
- Perform other duties as assigned.
Founded in 1925, ATCC is a non-profit organization with a mission to acquire, authenticate, preserve, develop, standardize, and distribute biological materials and information for the advancement and application of scientific knowledge.
ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.