West Bend, Wisconsin
Manager of Quality Assurance and Regulatory Affairs Job Opening in West Bend, Wisconsin - Spaulding Medical has an opening for a Manager of QA and RA to join their growing team. Spaulding Medical is a new startup medical device company, looking to disrupt the industry and become a leader in the medical arena. We are looking for a strong candidate with a wealth of QA/RA knowledge to assist us in that venture. If you are someone who is looking for a challenge, and wants to get in on the ground floor of an exciting new organization this might be the perfect fit for you!
Position Snapshot:
Full Time
Generally M-F 8am-5pm
Health, Dental, Vision, Life, Short/Long Term Disability Insurance
401k
Generous Paid Time Off
Paid Holidays
Job Summary:
Ensures the planning, coordination, control, and continuous improvement of processes and methods to ensure conformance to internal and external quality standards at Spaulding Medical. Is responsible for all aspects of the Quality System, Quality Manual and other applicable documents. Oversees and directs the Regulatory Affairs of Spaulding Medical.
Essential Duties and Responsibilities:
Facilitate and implement improvements to the quality system while maintaining compliance with applicable Quality System Regulations and or ISO standards where applicable.
Lead activities in the following areas: Internal Quality Audits, CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, Quality Audits, and other associated tasks.
Ensure that the Quality System is in compliance with Regulatory and Quality System requirements.
Participate in the review and installation of technology products and equipment.
Facilitates ISO Registration audits, coordinates with management to implement corrective actions as required. Acts as Management Representative.
during customer, sponsor, or 3rd party audits and interactions.
Act as a Lead Auditor and Participate in audits
Assist with identifying non-conformances with requirements and provide suitable recommendations.
Assure that audit reports are completed to timelines
Ensure audit results are communicated to management
Ensure that suitable responses and action plans are provided for resolution
Support special projects requiring QA and RA input
Work with suppliers and production personnel in eliminating non-conformances to ensure product quality and continuous improvement.
Responsible for the Document Control system.
Acts as a Quality Management Representative in accordance with ISO 13485: Medical Devices Quality Management systems. Requirements for regulatory purposes.
Education and Experience:
Bachelors of Science Degree in a Quality Management, or in an Engineering field with a strong Quality background.
At least 3 years experience in the Pharmaceutical Industry and or Medical Device Industry with an understanding of the FDA GCP or GMP?s.
Job Type: Full-time
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