Quality Assurance Engineering Manager

5 days ago

Irvine, California, United States Prismatik Full time
Job Title: Quality Assurance Engineering Manager

Prismatik is seeking a highly skilled Quality Assurance Engineering Manager to lead our quality assurance team. As a key member of our organization, you will be responsible for ensuring that our products meet customer requirements and comply with US and international regulations.

Key Responsibilities:
  • Develop and implement quality assurance strategies to ensure product quality and compliance with regulatory requirements.
  • Lead a team of quality assurance engineers to ensure effective implementation of quality assurance processes.
  • Collaborate with cross-functional teams to identify and mitigate quality risks.
  • Develop and maintain quality assurance policies, procedures, and standards.
  • Conduct audits and assessments to ensure compliance with quality assurance standards.
  • Provide training and coaching to quality assurance engineers to ensure they have the necessary skills and knowledge to perform their duties.
  • Develop and maintain relationships with regulatory agencies and industry partners to stay up-to-date on the latest quality assurance standards and best practices.
Requirements:
  • Bachelor's degree in a related engineering discipline.
  • Minimum seven (7) years of related quality assurance experience.
  • Previous management and leadership experience.
  • Advance knowledge with development and test requirements with recognized standards (ISO).
  • Previous experience with New Product Development.
  • Demonstrated knowledge of the application of regulatory requirements for low-risk and high-risk software applications using a scalable approach.
  • Demonstrated knowledge and understanding on regulations and guidance as related to software development, SaMD.
  • Demonstrated ability to implement and improve Software QMS processes.
  • Previous quality assurance experience in materials manufacturing, preferred.
Benefits:
  • Competitive salary range: $111,956-$155,000/yr.
  • Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more.

Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.

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