Quality Manager NA Winston Screen Test

Primary Responsibilities and Essential Job Functions:

• Drive improvements to the quality system that ensures its suitability adequacy and effectiveness.

• Understand and ensure compliance with cGMP ISO 13485 and FDA 21 CFR Part 820 regulations.

• Provide operational support related to issue resolution product quality/risk assessment and product disposition.

• Assist in the investigation of non-conformances as the need arises.

• Conduct coordinate and review investigation of product complaints and assignment of root cause determinations when required. Determines if complaints require regulatory affairs involvement for adverse event evaluation.

• Provide QA support in the review and approval of plant related validation protocols reports and change requests.

• Provide facility quality support and representation in new product development scale up design transfer and facility validation activities.

• Represent quality and/or regulatory on core design change and new product development teams to ensure the design control process is followed effectively.

• Participate in the ISO 13485 certification process and regulatory inspection.

• Provide support in customer supplier and regulatory audits.

• Maintain quality systems and provide support for specific sections of the quality system as assigned.

• Develop and conduct training related to quality system and regulatory requirements.

• Develop quality SOPs to ensure compliance.

• Track and trend key Quality metrics.

• Supervise assigned direct reports per organizational charts.

• Perform other job duties as assigned.

Authority:

• Release new product development projects to Operations for production.

• Approve process changes as defined by Quality system.

• Approve or supervise those approving the release of product for shipment to customer.

Qualifications :

Required:

• Bachelors degree in Engineering or scientific related field.

• A minimum of 4 years of experience in the medical device or pharmaceutical industry with at least 3 years of experience in regulatory compliance and quality systems.

• Detailed knowledge of ISO 13485 and 21CFR Part 820.

• Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) and/or Certified Manager of Quality/Operational Excellence (CMQ/OE).

• Experience balancing multiple responsibilities with minimal direction.

• Strong written and verbal communication skills; strong presentation skills.

• Able to effectively work with various functions and levels within the organization.

• Willing and able to travel up to 25%.

Additional Information :

All qualified applicants will receive consideration for employment without regard to race color religion sex national origin sexual orientation gender identity disability protected veteran status or other protected status. EEOE/M/F/Vet/Disabled. All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Full-time