Quality Assurance Consultant

Quality Assurance Consultant - Cutting edge medical device company, helping make the world a better place!This Jobot Consulting Job is hosted by: Stephen BrainerdAre you a fit? Easy Apply now by clicking the "Apply" buttonand sending us your resume.Salary: $50 - $70 per hourA bit about us:Based in Topsfield, MA we are a well established and growing medical device company.We are dedicated to developing innovative medical solutions that enhance patient outcomes. Since 1992, we have been at the forefront of medical device innovation, specializing in wound healing, hemostasis, and severe bleeding control. Join our team and be part of a company that is committed to improving healthcare through cutting-edge biomaterials.If you are an experienced QA Specialist or Manager open to consulting 20 hours per week, then please apply!Why join us?Do you want to help make the world a better place AND enjoy time at home w/ family? We do too!Meaningful Work!Best in Class Organization!Flexible hours / hybrid schedule!Fun Company Activities!Many More!Job DetailsWe are seeking a dynamic and experienced Senior Quality Assurance Specialist to join our team! The successful candidate will be responsible for ensuring that our quality assurance processes optimized on a consulting basis. This is a vital role within our organization, and we need someone who is meticulous, detail-oriented, and committed to maintaining the highest standards of quality and improving processes.Responsibilities:Develop, implement, and maintain the Quality Management System to comply with ISO 13485 standards.Conduct regular audits to ensure adherence to the Quality Management System, identify areas of non-compliance, and recommend corrective actions.May prepare detailed nonconformance reports that identify any deviations from the quality standards and propose remedial actions.Collaborate with cross-functional teams to ensure that the quality standards are understood and implemented throughout the organization.Review and approve quality documentation, including procedures, work instructions, and forms.Monitor and analyze quality performance data to identify trends, issues, and opportunities for improvement.Ensure regulatory compliance by staying updated on changes in quality regulations and standards, and updating the Quality Management System accordingly.Provide training and guidance on quality standards and procedures to staff.Participate in the review of design and production processes to ensure quality considerations are adequately addressed.Lead problem-solving efforts relating to quality issues, and work closely with operations teams to implement solutions.Qualifications:Bachelor's Degree in Chemistry, Biology or a related field is required.Minimum of 10+ years of experience in a quality assurance role in a regulated industry.In-depth knowledge of ISO 13485 standards and experience in implementing and maintaining a Quality Management System in compliance with these standards.Proven experience in preparing nonconformance reports and devising corrective actions.Excellent skills in reviewing and approving quality documentation.Strong analytical skills, with the ability to analyze quality performance data and identify areas for improvement.Excellent communication skills, with the ability to explain complex quality standards and procedures in a clear and understandable manner.Strong problem-solving skills, with the ability to lead efforts to resolve quality issues.Ability to work collaboratively with cross-functional teams to ensure the implementation of quality standards throughout the organization.Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Created: 2025-02-13