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QA Manager

Company: Medpoint, LLC
Location: New Prague
Posted on: August 7, 2022

Job Description:

Medpoint is seeking candidates for this critical QA Manager position located in New Prague, MN. This is an exciting and dynamic organization in the life sciences industry that is seeking strong leaders with strong background in quality, quality management systems, and compliance. Regulated industry experience is a must, medical device experience is preferred. POSITION SUMMARY:The Quality Assurance (QA) Manager assists the VP of Quality and Regulatory Compliance ensuring compliance within the company's Quality Management Systems (QMS) adhering to all various state, federal, and international laws/regulations that apply to business operations. The QA Manager must coordinate with other departments and co-workers to operate and perform critical due diligence of processes.This position is responsible to manage and improve processes to ensure products or services are designed and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration (FDA), Health Canada, European MDD/MDR and others as required. This role will also participate in the implementation of improvements to the company's QMS element procedures, including Nonconformance Material processes, Customer Complaint management, Adverse Event (AE) reporting, Corrections and Recall handling, Corrective and Preventive Action (CAPA) process, Inspection and other quality assurance duties.Manages QMS processes to ensure regulatory and internal policy compliance and continual improvement of those processes. A strong contributor to complex projects within the Quality and Regulatory Departments. Accountable for meeting internal and external quality objectives. Supports Regulatory and Operations in efforts to drive product and process improvement, as well as the development of technical documentation to meet 3rd party regulatory standards, including but not limited to FDA, MDSAP/ISO 13485, and the Medical Device Regulation (MDR). SCOPE:

  • Provide leadership of the Quality Management System (QMS), including the implementation and improvement of specific QMS elements to ensure ongoing compliance with US FDA, EU Medical Device Regulation (MDR), and other required regulatory standards
  • Engage in continual improvement activities by leading processes related to CAPA, Nonconforming Material, Complaint Management, AE reporting, Corrections and Recall handling, Change Control and other related quality system processes
  • Develop processes for the effective generation of metrics for all QMS elements, including established Key Process Indicators (KPI), for use within the department and upper management
  • Maintain knowledge of relevant quality and regulatory standards and augment quality system processes to meet changing requirements, including the MDR, FDA, MDSAP and others as required
  • Participates in special projects and perform other duties as required
  • Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements
  • Supports Regulatory Affairs in their effort to achieve and sustain compliance with regulatory standards, including FDA and European requirements
  • Assist with regulatory audits and inspections
  • Participate in the gathering, development and presentation of data that reflects the status and implementation of the QMS
  • Create/draft, update and review Standard Operating Procedures (SOPs)
  • Direct and supervise daily activities of QA/QC staff involved in receiving, in-process and final inspection, complaint investigation, Corrective and Preventive Action (CAPA) process and document control to ensure compliance to quality standards/regulations.
  • Manage private labeling activities (UDI, artwork review)
  • Support product Safety Data Sheet (SDS) requests and maintenance SUPERVISORY RESPONSIBILITIES:Performs supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include training employees; planning; assigning and directing work; evaluating performance; addressing complaints and resolving problems.Work under minimal supervision and may act independently to determine methods and procedures on new assignmentsEDUCATION REQUIREMENTS: --- Bachelor's Degree required --- Bachelor's Degree in an engineering field or other technical science preferred. QUALIFICATIONS:
    • A minimum of 10 years prior experience in Quality Assurance
    • A minimum of 5 years prior experience in Quality Assurance Management
    • Relevant training / certifications, for example, ASQ Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) preferred.
    • Solid experience with implementation and improvement of 21CFR820 and/or MDSAP (ISO 13485) QMS elements
    • Strong attention to detail
    • Demonstrated experience working with regulatory bodies, contract manufacturers, suppliers and distributors.
    • Comfortable working within a fast growth and changing environment
    • Demonstrated ability to effectively communicate and influence decision makers.
    • Experience in quality systems and audits.
    • Knowledge of various Quality System and Regulatory Standards that are applicable to temperature-controlled logistics and transportation business elements and future GMP Compliance.
    • Experience working in cross functional organizations.
    • Strong communication and interpersonal skills.
    • Excellent written and verbal communication skills with the ability to listen, articulate and advocate.
    • Proactive, high performance result oriented and manage projects with ethical integrity.
    • Manage multiple projects and deadlines
    • Ability to identify compliance risks and escalate when necessary
    • Demonstrate both creative and critical thinking skills
    • Hold a Six Sigma Green Belt or Black Belt or willingness to work towards attainment.
    • Advanced training/experience in the use of statistical techniques and process improvement methods.PHYSICAL DEMANDS:While performing the duties of this job, the employee is regularly required to stand, walk and sit. The employee frequently is required to use hands to finger, handle or feel objects, tools or controls and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.WORK ENVIRONMENT: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Employee is frequently required to sit. While performing the duties of this position, the employee is subject to a typical office environment. The noise level in the work environment is usually low to moderate.While performing the duties of this job the employee is occasionally exposed to fumes or airborne particles.COMPETENCIES:
      • Excellent independent decision making, analysis and problem-solving skills
      • Ability to plan and manage successful projects; understand available resources, develop timeline, budget, assign tasks and areas of responsibility
      • Excellent planning and organizational skills and techniques
      • Good negotiating skills and ability to effectively manage outsourced relationships
      • Strong time management skills and the ability to prioritize work
      • Resourceful, well organized, highly dependable, efficient and detailed oriented
      • Customer service oriented and ability to work with and resolve complex issues
      • Excellent interpersonal communication skills
      • Excellent written and verbal communication skills
      • Excellent analytical abilities
      • Oversee small projects
      • Establish productive working relationships at multiple levels within the organization
      • Common business-related computer hardware and software, MS Office. PERSONAL ATTRIBUTES:
        • Passion and alignment with mission, vision, values & operating principles.
        • Desire for working in a values-based company in alignment with a learning organization.
        • A change agent and strong collaborator who is not afraid of challenging status quo.
        • An individual who brings strong core values, quality, ethics, and integrity
        • A collaborative team player who embraces and champions the culture
        • Strong work ethic and ability to deliver results and meet commitments in a dynamic environment
        • Exceptional and dynamic communications skills with the ability to inspire and influence people at all levels, build consensus and commitment, and effectively drive change throughout the organization at a rate that fits the corporate culture
        • Exceptional organizational and planning skills, strong analytical abilities, and process orientation
        • Desire to own decisions and take responsibility for outcomes.
        • Willingness to travel when required.
        • Willingness to continually embrace personal and professional development.PREFERRED SKILLS:
          • Excellent computer skills including Microsoft office suite of products (Word, PowerPoint, Excel, etc.)
          • Understanding of GMP regulations
          • Experience with IATA DG regulations, specifically Class 6.2, Conformite Europeenne requirements, etc.
          • Experience with EDMS systems and implementation.

Keywords: Medpoint, LLC, Minneapolis , QA Manager, Executive , New Prague, Minnesota

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