Great career opportunity with Global Manufacturing Leader for an experienced Quality Manager to strategically develop, implement and lead the plant QA, QC, ISO and Export compliance programs. Requires strong leadership and communication skills with expertise in managing cross-disciplined teams.
— Lead directives for Quality Assurance, Quality Compliance (including Export Controls) and Validation focus. Implement activities/projects, audits and reports to support requirements.
— Initiate, develop, and implement a quality excellence mindset for plant site, creating cultural initiatives and improvements.
— Lead and validate key quality functions for the site. Ensure the validation plans, execution strategies, projects and acceptance criteria are based on established site, industry and regulatory standards.
— Provide technical expertise and ensure timely investigation/resolution of customer complaints or regulatory issues.
— Oversee complaint investigations, internal notifications, internal audits, supplier audits and CAPA systems. Represent the site on all customer audits.
— Manage ISO certification initiative to meet corporate compliance. Be the site expert for ISO certification requirements for ISO 9001 and 13485.
— Manage the QC lab including coaching and developing the lab technicians, budget control, procedural improvements and SSHE performance of the department.
— Enhance the Company QA reputation with applicable regulators, customers and certifying agencies.
— Review trial reports before making release decisions and review/approve validation protocols for new product validations
— Responsible for tracking/trending of critical quality KPI’s on a monthly and quarterly basis to support local and global reporting.
— MS or BS Chemical Engineering or related Science degree and 6+ years experience as Quality Manager with expertise in ISO (9001 and 13485) regulations. Ideal industry background includes fibers, resins, textiles, plastics,, medical devices or composites.
— Proven abilities to direct QA and QC programs as a change agent in manufacturing plant sites.
— Knowledge of cGMP, validation and global export compliance is desirable.
— Requires expert skills in use of Microsoft Office, SAP, Lean/ Six Sigma tools.
— Able to work in the USA without sponsorship, now or in the future.