Senior Quality Manager
Company: Osypka Medtec Inc.
Posted on: February 23, 2021
- Work independently and oversee members of the quality
- Act as quality liaison between internal stakeholders, external
stakeholders, and customers.
- Working knowledge of statistical calculations, equations, and
- Ensure compliance to applicable statutory and regulatory
- Prepare reports for the Board of Directors, management team,
customers, and suppliers.
- Identify and implement continuous improvements in the Quality
- 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
- 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
- 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
- Guide company through quality and regulatory landscape.
- Ability to perform quality manufacturing functions, including
component inspections, in-process inspections, and other hands-on
- 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
- Act as point of contact for quality and regulatory
- 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
- 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,
- Support the organization in documentation and performance of
process validation, design verification/validation, and test method
- Recommend, implement, and maintain continuous improvement
- Maintain a positive and professional working relationship
between the quality team and other departments using a partnership
- 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
- 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
- Ability to work independently and collaboratively in a
- Ability to prioritize in urgent situations.
- Willingness to perform other duties as required, directed or
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
- Must have strong oral and written communication skills and
- Accuracy, attention to detail, and organizational skills are
- Relevant quality certifications (e.g. Lead Auditor, ASQ, etc.)
- Familiarity with MDD/MDR preferred.
- 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
- Ability to travel by car, plane or train. Travel up to 20% of
- $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
- 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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