Jun 29, 2021

Quality Systems Engineer

  • Greenlight Guru
  • Remote
Full time Cybersecurity Quality Regulatory

Job Description

At Greenlight Guru, our innovative software helps medical device companies focus on products that improve the quality of life for millions of people. Our innovative SaaS offering is revolutionizing how Medical Device companies invent, design, manufacture, sell, and support their products. 

We have an exciting opportunity for a Quality, Security, and Compliance Engineer to join our Quality Assurance team. You will be responsible for strengthening the integrated Quality and Information Security Management Systems (QMS/ISMS) processes by employing best practices to ensure compliance to applicable standards, regulations, and internal policies in a fast-paced, high-growth SaaS environment. The Quality, Security, and Compliance Engineer will help the organization meet ISMS, General Data Protection Regulation (GDPR), and California Consumer Privacy Account (CCPA) requirements. Implement improvement initiatives while ensuring compliance with applicable new requirements and standards published. This individual will be instrumental in acting as a point of contact for internal and external audits activities. 

Primary Responsibilities

  • Monitor compliance with the GDPR, CCPA, and other applicable data protection laws and policies established for the protection of all data.
  • Ensure operating procedures comply with all relevant data security, privacy laws, regulations, and internal policies. 
  • Serve as a primary point of contact regarding data security and privacy rules best practices.       
  • Support the evaluation of the security controls implemented from the operational point of view as well as other security audit activities
  • Ensure the integrity of the QMS and provide support during Corrective and Preventive Action (CAPA) activities.
  • Support the Internal Audit program, including tracking and follow-up on audit findings.
  • Partner with process owners to generate metrics that can be easily reported on to identify areas of concern.
  • Propose process improvement opportunities based on continued analysis and monitoring of metrics, goals, and objectives.
  • Maintain procedures, work instructions, and forms, as necessary to ensure standardization of practices.

Requirements

  • Strong interpersonal communication skills and ability to work effectively across all levels of the organization.
  • Prior experience with ISO 9001, ISO 27001, and GDPR
  • ISO 13485, FDA 21 CFR 820, and EU  regulations for medical devices and pharma products are a plus.
  • Strong written and presentation skills 

Additional Requirements

  • Must be legally authorized to work in the US.
  • Bachelor’s degree or equivalent and minimum of 7 years of relevant experience with 5+ years of Quality Assurance / Quality Systems experience, and/or Information Security Management Systems Experience (FDA-regulated industry preferred).
  • Certified Quality Manager, Engineer, or Auditor, or previous auditing experience is a plus.

Benefits:

  • Co-workers who care deeply about our mission to spur medical device innovation and about helping each other become better engineers
  • Flexible hours
  • Work from home options
  • 3 months paid parental leave 
  • PTO
  • Health insurance
  • Disability insurance
  • 401k

If this describes you and you are excited about embracing change and aggressive growth, we are looking forward to meeting you. 

Greenlight Guru is an Equal Opportunity Employer. Individuals seeking employment at Greenlight Guru are considered regardless of race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. 


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