Job Information
COMAR LLC Quality Assurance Manager in Buena, New Jersey
Are you a Quality Professional with experience in the Manufacturing Industry? Are you looking for a new challenge and an exciting opportunity to influence a CDMO company, that is aggressively growing in medical devices and packaging business? Do you want to advance your knowledge, skills and career in a great working environment? Would you like to have a job that rewards performance and offers competitive compensation and benefits?
We are looking for a hardworking and enthusiastic Quality Manager to join our Plant Quality team and help us drive operational excellence and a culture of quality and compliance throughout our facility. This position is the appointed Management Representative responsible for quality at Comar's Buena, NJ and Vineland, NJ manufacturing sites. This position reports into Corporate Quality with dotted line reporting to the Plant Manager.
THE ROLE
Drive Plant Performance in Quality, Delivery, Cost and Customer Service * Drive quality is a service thinking and partner with Plant Management Team and other key stakeholders to improve quality, delivery, cost, and consumer service metrics for the plant. * Lead and manage Quality Function at the site. * Build, lead and manage a high performing team of subject matter experts and supporting resources to deliver functional and business objectives. * Interface with customers for various customer requests, issues, and audits. * Represent site to customers and external authorities for various audits as well as related quality and regulatory topics.
Manage and improve Key Corporate and Site QMS Processes * Coordinate with Corporate Quality and Plant Management to manage and improve quality procedures/processes for better operational quality on the plant floor
Provide Quality Control, Metrology, Quality Engineering and Validation support to Operations, Engineering and Quality Teams * Support day to day operation projects, troubleshooting and continuous improvement * Stand-up, operate and maintain necessary Quality Control and metrology labs. * Develop and conduct DOEs, statistical analysis, capability studies etc. for qualifications, troubleshooting or process improvements. * Develop and execute on qualifications protocols
Execute Audit and Compliance Program * Collaborate with Corporate Quality for continuous improvements to the Audit & Compliance Program. * Own ongoing execution of the Audit & Compliance program to improve compliance with the procedures and standards, successful completion of the audits and ensure audit readiness at all times
Promote a culture of Quality Awareness and Employee Engagement in the QMS * Train, coach, motivate and develop plant teams in the areas of Quality Improvement, Quality Policy, Measurement and Analysis, Quality Metrics, Customer Satisfaction (NPS) and Quality Systems/ISO requirements. * Develop Quality department performance goals and objectives. * Own Organization Planning and other HR processes for the site Quality organization. * Develop communication and training plans for Quality Awareness and Engagement.
WE ARE LOOKING FOR: * Bachelors degree from four-year College or University in Business, Science, Engineering, or a related field; 7+ years of hands-on Plant Quality Operations or Quality Management Systems (QMS) implementation experience as a Quality Manager * Thorough knowledge of regulated Industry, CFR Part 820 Quality System Requirements, MDSAP program, the ISO family of standards, particularly ISO 13485 and ISO 9001 * Experience in plastics processing technologies serving the packaging, pharma, and medical device markets. * Experience with training, validation processes and Statistical Process Control (SPC). * 5+ years of experience in managing team of salaried and/or hourly employees. * Certifications: Quality Management or Quality System Auditing, i.e., ASQ CQM/OE or CQA