Quality Assurance Supervisor

1 week ago

Northbrook, Illinois, United States DiaSorin Full time
Job Title: Quality Assurance Supervisor

At DiaSorin, we are seeking a highly skilled Quality Assurance Supervisor to lead our quality assurance team and ensure compliance with domestic and international quality system standards and regulations for commercial medical devices.

Key Responsibilities:
  • Lead, establish, implement, and maintain quality assurance systems and activities
  • Provide technical and operational leadership for Quality Assurance activities, Quality System development and implementation, validations, and process development
  • Manage, lead, and mentor Quality Assurance department and personnel
  • Promote, mentor, and coach staff for growth
  • QA lead in Risk Management activities, including responses to complaints and recalls
  • Quality lead in production team meetings and on-market product technical reviews to ensure quality assurance requirements are met
  • Integral member of production teams, responsible for ensuring compliance during the design transfer and production process
  • Regularly review quality system standard operating procedures and work instructions, making changes as necessary to ensure compliant and efficient Quality Assurance processes
  • Provide input to the Management Review and Quality Review Board processes and monitor the Quality Management System (QMS), and provide training throughout the organization
  • Respond to identified and potential nonconformities, complaints, deviations, and corrective/preventative actions assigned to Quality Assurance
  • Participate in Audits - internal and external, as SME or escort
  • Key member of select Review Boards as per Quality processes (e.g., MRB, CRT, ORB, SRB)
Requirements:
  • Bachelor's degree in a life science/engineering discipline or minimum 5 years' work experience in a regulated/medical device industry required
  • 3+ years Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 14971
  • 1+ years Management experience in a complex quality assurance/quality systems field
  • Ability to provide leadership to others in the organization through influence, innovative practices, and coaching skills to foster a corporate culture of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance
  • Possesses a strong scientific and technical background, sufficient to establish creditability with senior management as well as the manufacturing and product development teams
  • Excellent problem-solving methodology, using industry-accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues
  • Hands-on ability to sort through technical complexities and work in a flexible changing environment
  • Excellent interpersonal, verbal, and written communication skills
  • Thorough knowledge of standards and regulations (cGMP, ISO 13485)
  • Highly organized with proven time management and prioritization skills
  • High degree of problem-solving, attention to detail, and analytical skills
  • Certification in a quality discipline preferred, such as CQM, CQA
  • Ability to work independently and with minimal supervision
  • Experience working independently in a fast-paced environment with rapidly changing priorities
  • Travel, local and international travel may be required approximately 10% of the time
What We Offer:

At DiaSorin, we offer a competitive salary and benefits package as you grow your career with us. Join our team and discover how your work can impact the lives of people all over the world.

DiaSorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

DiaSorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at [insert contact information].

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