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.
        Compensation:
        • $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