Quality Assurance Manager

Company: Grey Search + Strategy
Location: Burnsville
Posted on: June 20, 2022

Job Description:

ABOUT THE COMPANY:Our client is a leading manufacturing, marketer and supplier of pharmacy supplies and consumer goods based in the Twin Cities South Metro, with several manufacturing and vendor partners in the U.S. and internationally. They have many trusted brands in the marketplace and function as an omni-channel company selling products wherever consumers shop. The company's caring culture and values ensure they have a lot of fun while performing at a high level.ABOUT YOU:The Quality Assurance Manager is accountable for developing, implementing, coaching, and executing on the our client's QMS with a hands-on approach. You will provide leadership to the Quality Assurance team, and consider their site affiliations (United States, Hong Kong, United Kingdom, Netherlands) when deploying QMS systems and controls. You will also support the Regulatory Affairs team on periodic needs to meet regulatory and customer requirements. With a mix of strategic and tactical responsibilities, this opportunity will allow you to expand your skill sets and see results of your efforts real-time.RESPONSIBILITIES:

• Provide hands-on assistance and leadership in the effective day-to-day implementation and functioning of the QMS at the Burnsville and other affiliated facilities; Coordinate and track internal and external audits and inspections, third-party product testing, investigating customer complaints, control of nonconforming product, training and QMS metrics and management reviews
• Perform critical analysis of quality data to identify any trends or patterns of problems that require corrective or preventive action, including internal audits, complaints, nonconforming product and supplier quality metrics
• Monitor GMP practices in the production and warehouse areas through audits and walk-through reviews to ensure that these meet regulatory and procedural requirements; report on findings and actions to correct any anomalies
• Oversee the effective implementation, validation and operation of the Grand Avenue eQMS modules.
• Supervise the QC Inspectors and Document Control Specialist, and the development and optimization of work practices, systems and procedures
• Ensure that incoming products and materials are inspected and dispositioned correctly; determine inspection criteria, create and implement function test methods, establish the inspection criteria and sampling plans to ensure products meet specified requirements and customer expectations
• Investigate customer product issues and third-party test facilities; work with other company functions to identify/implement effective solutions; keep customers informed of the status and outcomes
• Develop product quality plans for new and existing products, identifying critical-to-quality attributes and controls to ensure that the product meets its intended performance specifications
• Assist with the validation of new/changed products in accordance with specified requirements and applicable inspection criteria
• Coordinate product testing to meet regulatory and customer specification/contractual requirements
• Participates in risk analysis and risk reviews on products and processes
• Support Regulatory Affairs with activities relating to demonstrating compliance with government and product related regulations
• Lead by example by following company policies, standards and specifications to ensure effective consistent administration of practices, procedures and policies
• Directly manage employees to ensure effective staff planning, selection, retention, development, disciplinary action and performance management; conduct regular team meetings
• Stays abreast of the team member climate/culture to ensure solutions to problems are developed while issues are minor; collaborate with V.P. of Quality & Regulatory and Human Resources on employee relations issues, including but not limited to discipline and development
• Provide back-up to quality inspectors and Document Control SpecialistEDUCATION + EXPERIENCE
  • Bachelor's degree or equivalent in a technical or engineering discipline
  • At least five years of quality management system and compliance leadership experience in a regulated industry
  • Leadership of a quality and compliance team
  • Internal auditing or ASQ certification a plus
  • Working knowledge of the Consumer Product Safety Commission requirements is a significant advantageSKILLS + ATTRIBUTES
    • In-depth knowledge and practical application of FDA 21 CFR Part 820 Quality System Regulation, Good Manufacturing Practice for Medical Devices, and ISO 13485: 2016
    • Ability to problem-solve and conduct thorough investigations into formulating root cause and developing and implementing practical and cost effective solutions
    • Detail oriented, organized, and capable of working effectively with minimum supervision
    • Ability to work effectively with cross-functional staff and in a team
    • Ability to communicate and work effectively with internal employees and external stakeholders, including customers, suppliers and regulatory bodies
    • Possess an understanding of quality-related principles, tools and techniques
    • Working knowledge of MS Office -- Willingness to continuously learn and be open to feedback
    • Verified personal and professional values aligning with APL
    • Willingness to work overtime as needed, and be able to work well under deadlines

Keywords: Grey Search + Strategy, Burnsville , Quality Assurance Manager, Executive , Burnsville, Minnesota