Senior Quality Manager
Company: Osypka Medtec Inc.
Posted on: June 10, 2021
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
Didn't find what you're looking for? Search again!