Responsible for managing the quality and compliance for applicable products and processes for assigned department(s) at the manufacturing sites. Adapt departmental plans and priorities to address resource and operational challenges. Liaison with site operation management providing input and support to ensure Quality and Compliance requirements are being met.
Responsibilities- Management Representative for the site to ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product.
- Ensure appropriate inspection and test methods are followed for incoming, in-process and finished product release to ensure product is in alignment with applicable regulations.
- Representative for the site Quality and Compliance. Manage and develop and train a team of quality staff.
- Host Internal and External quality audits. Organize the Quality team and site management for audit preparation and processes to support audits.
- Acts as a liaison with the Divisions, Suppliers, Manufacturing, Regulatory, Sterility Assurance, Recall Management and/or Operations to ensure quality products and customer satisfaction.
- Investigation of manufacturing-caused customer complaints, providing feedback, and taking appropriate corrective actions, which may include developing and sponsoring new approaches to solving manufacturing problems with no adverse impact on the product or processes.
- Manage the site's Nonconforming, Deviations, and CAPA processes. Conduct Root Cause Investigations, develop and implement corrective actions related to the respective product or process, and determine effectiveness as applicable.
- Oversee the execution of Management Review and trending processes. Communicate Quality Trends and Quality System needs to upper management as needed.
- Identify, manage, and support continuous improvement and cost savings projects.
- Align Quality goals with site operational goals, providing input to support business KPI's and defined objectives for manufacturing operations
- Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint. Assist in the planning of the design, testing, inspection, and process validations to assure quality products or components and alignment with applicable regulations.
- Management responsibilities may include:
- Oversees professional employees/teams OR manages non-professional employees through Supervisors in manufacturing, distribution or office environments
- Oversight of plant to ensure appropriate process controls are in place and implements corrections if quality metrics indicate improvement is needed
- Oversight of raw material, in-process and finished good quality control processes
- Managing relationships with suppliers, divisional partners, corporate resources
- Day-to-day operations of a group of employees
- May have limited budgetary responsibility and balances QA impact to site budget
- Interpret and execute policies for departments/projects and develops.
- Recommend and implement new policies or modifications to existing policies in accordance to updated standards, regulations, or quality metrics.
- Assigning responsibilities to direct report staff,
- Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.
Qualifications- Bachelor's degree in Engineering, Science, or Technical Field.
- 4+ years of experience related to the manufacturing of medical devices and/or drug/cosmetic product platforms.
- Related experience may include: design controls, risk management, including working in compliance with QSR/GMP/ISO requirements, supervising or managing QA/QC/Laboratory staff in support of Device/Drug/Cosmetic Manufacturing, or other similarly regulated industries (21CFR 820, 21CFR210/211, ISO 13485, ISO 14971, MDSAP, and MDR)
- Strong knowledge of FDA regulations, ISO 13485, and industry best practices.
- Exceptional writing, proofreading, and documentation skills.
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