- Develop, implement, and manage the site Quality Management System (QMS) that aligns with industry standards and organizational objectives.
- Facilitate quality and continuous improvement initiatives to enhance operational efficiency, customer satisfaction, and overall performance.
- Lead all quality efforts at the plant to ensure that our products consistently meet or exceed defined quality standards and customer expectations.
- Collaborate with cross-functional teams to identify and implement quality improvements, drive process optimization, and achieve cost-effectiveness.
- Ensure timely resolution and closure of Corrective and Preventive Action (CAPA) plans.
- Conduct regular audits and assessments to evaluate the effectiveness of the QMS and processes, identifying areas for improvement.
- Analyze quality performance data and metrics to identify trends, develop insights, and drive data-driven decision-making.
- Establish and monitor key performance indicators (KPIs) to track the effectiveness and efficiency of quality processes and continuous improvement initiatives.
- Ensure site adheres to local regulations and industry standards for pharmaceutical packaging and printing.
- Provide training and mentorship to employees to enhance their understanding of quality principles, practices, and methodologies.
- Oversee supplier quality management, including supplier evaluations and audits, to ensure the quality of incoming materials and components.
- Represent the facility in dealings with external stakeholders related to quality and continuous improvement.
- Assist the General Manager in driving a culture of quality excellence, continuous improvement, and accountability.
- This role will have supervisory responsibilities over the Quality Department, and it is expected that this individual will have previous experience leading successful teams.
- Bachelor's degree in a related field (e.g., Quality Management, Engineering, Business Administration) is preferred.
- Minimum of 5 years of experience in quality management within the printing, packaging or pharmaceutical industries, with a proven track record of improving quality standards and processes.
- Expertise in ISO 9001 (Quality Management Systems) and ISO Primary Packaging Materials for Medicinal Products) standards
- Expertise with FSC, SFI and PEFC environmental certifications and system maintenance
- Prior experience managing direct reports and leading teams to drive quality improvements and standardization efforts.
- Understanding of pharmaceutical industry regulations, including cGMP, FDA, and international quality standards.
- Strong analytical skills with the ability to analyze data, identify trends, and implement effective solutions.
- Excellent communication and interpersonal skills to lead and collaborate with cross-functional teams, direct reports, and stakeholders.
- Proficiency in quality management systems, data analysis tools, and software applications.
- QCBD Software Experience is a plus
- Relevant certifications such as Certified Quality Manager (CQM) or Certified Quality Auditor (CQA) are advantageous.
- Lean Six Sigma certification is a plus
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Quality Assurance Manager - Garner, United States - Resource Label Group
Description
RLG Healthcare, a division of Resource Label Group, LLC, leads the way in providing innovative packaging solutions to the Healthcare market. RLG Healthcare provides a one-stop shop for all pharmaceutical packaging needs including labels, folding cartons and boxes, inserts, outserts, IFUs and DFUs, Med Guides, and physician support literature. Our industry-best lead times are made possible by our coast-to-coast manufacturing footprint and our dedicated team of packaging specialists with a passion for quality and service.
As RLG Healthcare continues to grow, we are always looking for talented individuals to join our team Every person in our company contributes to our success. We offer an employee centric, collaborative culture that is technology driven and focused on delivering valuable, creative solutions. Our core values embody the way we interact with each other just as it influences the way we interact with clients.
We are currently seeking a highly motivated and experienced Quality Assurance Manager to lead our commitment to quality, operational efficiency, and excellence at MedLit Solutions in Garner, NC. As the QA Manager, you will be responsible for developing, implementing, and maintaining a comprehensive Quality Management System and play will play a key role in fostering a culture of quality, efficiency, and continuous improvement at the facility.
Responsibilities:
Qualifications:
