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Senior Quality Manager

Company: Osypka Medtec Inc.
Location: Longmont
Posted on: February 23, 2021

Job Description:

General Competencies:

  • Work independently and oversee members of the quality team.
  • Act as quality liaison between internal stakeholders, external stakeholders, and customers.
  • Working knowledge of statistical calculations, equations, and analysis.
  • Ensure compliance to applicable statutory and regulatory requirements.
  • Prepare reports for the Board of Directors, management team, customers, and suppliers.
  • Identify and implement continuous improvements in the Quality Management System.
  • Establish and maintain effective working relationships with fellow employees, customers, and suppliers.
  • Lead internal and external audits by customers, notified bodies, and other regulatory organizations.
  • Ensure supplier quality through qualification, audits, and monitoring.
  • All employees are expected to provide customer service; communicate in an effective manner; display professionalism and integrity; and work efficiently. Employees should take initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.
    Essential Job Functions:
    • Responsible for maintaining and ensuring the effectiveness of the Quality Management System.
    • Responsible for fulfilling the responsibilities of the Management Representative in accordance with regulatory and quality system requirements.
    • Responsible for complaint handling and investigation in accordance with regulatory and quality system requirements.
    • Responsible for managing CAPA system.
    • Flexibility in resolving issues while maintaining compliance.
    • Guide company through quality and regulatory landscape.
    • Ability to perform quality manufacturing functions, including component inspections, in-process inspections, and other hands-on activities.
    • Develop quality objectives and lead efforts related to the company's quality vision.
    • Provide input to management regarding strategic priorities from a quality perspective.
    • Act as intermediary between company and customers to define quality agreements.
    • Act as point of contact for quality and regulatory communications.
    • Serve as lead auditor, prepare for internal audits, host external audits, and address non-compliance issues for both internal and external audits.
    • Responsible for ensuring supplier quality and product conformance.
    • Ensure conformity of product and adequacy of lot records prior to shipment of product. Responsible for monitoring and trending of manufacturing environment and processes.
    • Responsible for the supervision, training, development, mentoring, and coordination of the quality team.
    • Oversee the following additional quality functions (GMP, Control of Records, Risk Management, Internal Audits, Cleanroom and Environmental Controls, Equipment Maintenance and Calibration, Training)
    • Support the organization in documentation and performance of process validation, design verification/validation, and test method validation activities.
    • Recommend, implement, and maintain continuous improvement activities.
    • Maintain a positive and professional working relationship between the quality team and other departments using a partnership approach.
    • Work with quality and engineering team to ensure development projects conform to design control and project requirements.
    • Work with engineering team to determine project schedule by developing project plan and requirements.
    • Work with engineering and manufacturing team to define appropriate product-specific quality controls and process monitoring requirements.
    • Maintain safe and clean working environment by enforcing procedures, rules, and regulations.
    • Comply with federal and state regulations and industry requirements and standards.
    • Maintain and encourage open lines of communication with customers.
    • Ability to work independently and collaboratively in a fast-paced environment.
    • Ability to prioritize in urgent situations.
    • Willingness to perform other duties as required, directed or assigned.
      Education and Experience:
      • Bachelor's degree in relevant field preferred.
      • 8+ years of quality experience in regulated manufacturing environment required; medical device preferred.
      • 2+ years leadership/management experience preferred.
      • Intimate knowledge of FDA, ISO 13485 and medical device regulations required.
      • Must have strong oral and written communication skills and computer skills.
      • Accuracy, attention to detail, and organizational skills are critical.
      • Relevant quality certifications (e.g. Lead Auditor, ASQ, etc.) preferred.
      • Familiarity with MDD/MDR preferred.
        Physical Demands:
        • Ability to sit or stand for long periods of time.
        • Ability to lift, bend or move up to 40 pounds.
        • Ability to use inspection equipment, including microscopes.
        • Ability to travel by car, plane or train. Travel up to 20% of the year.
          • $90,000 to $125,000 Depending Upon Qualifications
          • Paid Vacation
          • Paid Personal Time Off and Holidays
          • Paid Sick Leave
          • Partial Payment by Company of Group Health Insurance
          • 401(k) with limited company matching
            Additional Information:
            • No relocation will be provided by the Osypka Medtec.
            • Candidates must be authorized to work in the USA.
            • Osypka Medtec will not sponsor H1B visas.

Keywords: Osypka Medtec Inc., Longmont , Senior Quality Manager, Executive , Longmont, Colorado

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