Manufacturing Quality Manager
Job DescriptionJob Description
CONTRACT TO PERMANENT POSITION / FULL TIME
RATE: BASED ON QUALIFICATIONS
WORK SCHEDULE: Monday to Friday, 8 AM to 5 PM
POSITION SUMMARY
The Quality Manager at our client’s Belen site is responsible for managing and overseeing the Quality Department. He must fully understand the requirements for the product or service and have a sense of responsibility towards our potential and existing customers as well as the competition.
This includes day-to-day inspections of the final product to make sure it has been built in compliance with legal standards and meets customer expectations. The quality manager should be thorough with an eye for detail, observant and ensure that the department operates within budget and output targets, with full accountability for ensuring safety, customer quality, cost and on time delivery requirements are met. This position reports to the Site Manager – Belen.
Client is committed to maintaining a diverse workforce and an inclusive and equitable work environment. This includes all employment-related decisions and business dealings based on , , , , , , , , , veteran status, or any other legally protected status.
RESPONSIBILITIES & DUTIES
• Implement and improve the system management for the ISO 9001 and ISO 15378.
• Lead the risk analysis team. (lead FMEA or HACCP team) and ensure the follow up.
• Define & apply continuous improvement techniques- lean mfg., 8D, PDCA, etc., to solve quality problems.
• Apply structured meeting management techniques - creating & following an agenda, minutes, ground rules
• Ensure GMP rules adapted to our business are implemented, respected.
• Manage and approve documents into Client’s document retention system (GMS & LMS).
• Responsible for GMP and IPC training, and accountability for training efficiency.
• Ensure customer requirements are well defined and followed.
• Validate Customer Quality Agreements and questionnaires.
• Lead customer complaint process (CAPA) and the meetings with departments involved in the solution.
• Manage Quality independent from production to ensure all standards and requirements are met.
• Lead customer audits, and responsibility for audit follow up (CAPA).
• Lead improvements and ensure that root cause analysis methodology is well applied.
• Manage and document handling of returns and restricted materials.
• Serve as the site management representative during customer visits and/or audits
• Escalate any risk of product/material recall to Site Manager, including the criteria for recall.
• Escalate any issue (internal or external) to upper management including Client’s Global Quality team.
• Lead and coach the Quality team.
• Support Client’s Global Quality for system management improvements (e.g., SOPs), and serve as auditor for the system.
• Serve as a member of the site leadership team by collaborating with and supporting other departments.
• Other duties as assigned.
MINIMUM QUALIFICATIONS
• Bachelor Degree in Engineering discipline or Quality
• Minimum 10 years’ experience in Quality and people management
• ASQ Certification is required
• Experience in Lean Sigma methodology, 8D methodology, ISO 15378 is required. (specifically for manufacturers of primary packaging materials used in medicinal products)
• Black Belt certification/training is required
• Provide training on GMPs to the QA group and Production as needed.
• Train and develop QA staff and conduct Performance Reviews to assure highly effective, team-oriented contributors.
• Serves as QA expert in support of all manufacturing quality assurance functions (product release, product inspection, batch record reviews, compliance) and resolution of issues on the production floor
• Demonstrate Leadership skills and act as a resource for the other inspectors, and all other departments.
• Demonstrate basic mathematical skills, and ability to work with written instructions required.
• Ability to write and verbally communicate data, reports, and various lab documents and correspondence.
• Proficiency with quality terms, definitions, and concepts to support continuous improvement efforts.
• Demonstrate the ability to work with various lab & office equipment.
• Proven ability to work with various Microsoft office programs, as well of SAP.
• Effectively communicate with peers and other departments and exhibit excellent teamwork.
• Little to no guidance is provided by Supervisor.
WORKING LOCATION
• This position is based on-site at Client’s Belen, NM manufacturing facility.
• Travels for Vendor audits and customer visits as needed.
Company DescriptionBESTstaff is a New Mexico Small Business that has been providing quality staff augmentation for 15 years. The Albuquerque Journal through their Reader’s Choice Award Program has names BESTstaff as a top staffing firm for the last 8 consecutive years.Company DescriptionBESTstaff is a New Mexico Small Business that has been providing quality staff augmentation for 15 years. The Albuquerque Journal through their Reader’s Choice Award Program has names BESTstaff as a top staffing firm for the last 8 consecutive years.