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Senior Quality Manager

Company: Osypka Medtec Inc.
Location: Longmont
Posted on: June 10, 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, Other , Longmont, Colorado

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