Manufacturing Operations Quality Engineering support
5050 Nathan Lane N. Plymouth, MN 55442
Voca has an immediate opening available for a Manufacturing Operations Quality Engineering support in Plymouth, MN! Interested candidates will contact email@example.com, direct number (347) 293-2560.
Job Description:Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
Develops product and manufacturing quality plans to plan out strategic events within production
Leads and assists with process validation and inspection qualifications
Reviews and scopes quality documentation to determine product risks and qualification strategies
Creates and reviews risk assessments, including PFMEAs to evaluate product and process risks
Collaborate with suppliers and/or third party manufacturing companies on product enhancement, support, and development
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Appropriately document experiment plans and results, including protocol writing and reports.
Lead process control and monitoring of CTQ parameters and specifications.
Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.