Experienced Quality Assurance Engineer

Analytical skill, Application lifecycle management, Documentation, FDA, Compliance, Internal auditing, QA, QMS, Risk analysis, Startups, Specification, Engineering, Gap analysis, ISO 13485, ISO 9000, Project documentation, Product development, Quality management
Full Time
Depends on Experience

Job Description

About Sterling Medical Devices:

Sterling Medical Devices, a provider of custom electro-mechanical and software solutions for the medical device industry, has been dedicated to helping our clients resolve medical device development challenges. Our engineering teams address the whole development process: systems, software, electronics, mechanical, quality, and compliance. Our headquarters, located in Moonachie, NJ, is a casual work environment that engages our team in cutting edge technologies and projects.

Sterling has over 20 years of experience working with doctors, startups, medical device companies and providing solutions for healthcare companies that need to scale up quickly to bring medical device software, hardware, mechanical, and mobile medical device apps to market by successfully navigating the FDA and CE approval process. We design our client’s products with a focus on the user needs and requirements, while making smart design choices based on our extensive and diverse product development experience.

 

The Opportunity:

We are currently searching for a Quality Assurance Engineer to join our team. This position will be responsible for working closely with a development team to provide technical, analytical review and feedback on project documentation for both software and hardware for state of the art medical devices to ensure that they not only meet good documentation practices but are also compliant to procedures and regulatory requirements. The ideal candidate is a self-starter with a passion for being part of a team developing medical technologies that improve people’s lives.

 

Essential Duties and Responsibilities:

  • Perform routine analytical technical review of project documentation like requirements specifications, verification protocols, plans, traceability reports, risk analysis.
  • Work with multiple project teams concurrently
  • Ensure document compliance with QSR and procedures.
  • Create, review, and update procedures (SOP), work instructions and project document templates
  • Participate in improvement of processes.
  • Brainstorm ideas to create solutions for identified problems
  • Communicate any documentation deficiencies to relevant personnel.
  • Interface with clients and draft reports and memos as directed.
  • Review and analyze other documentation as required.
  • Perform gap analysis of QMS to updated standards as directed
  • Perform additional Quality Assurance tasks as directed
  • Perform internal audits as directed
  • Perform tool validations as directed
  • Create training material as directed
  • Provide mentorship to junior QA and System Engineers
  • Light travel to customer sites (up to 10 days a year)

 

Education and Experience:

  • BS/MS degree in Engineering, Computer Science, or related subject (or possess the equivalent experience of such a degree)
  • 5+ year’s relevant experience within an ISO and FDA compliant Quality Management System is desired.
  • 5+ years experience working with Engineering documentation
  • 5+ years experience working with technical writing
  • Experience in development of work instructions and SOPs is a plus
  • Conducting internal quality system audits is a plus

 

Knowledge and Skills:

  • Applied knowledge of applicable regulatory standards: 21CFR820, ISO 13485, EN 62304, ISO 14971
  • Demonstrates good judgment
  • Ability to multi-task is essential
  • Good verbal, written and interpersonal communication skills
  • Good documentation skills and attention to detail
  • Excellent analytical skills
  • Ability to communicate effectively with all levels of staff and management, both internal and external
  • Self-starter with minimal supervision is essential
  • Detail oriented
  • High level of initiative with ability to self-manage
  • Strong interpersonal, communication and organizational skills with ability to work both independently and as part of a team
  • Proficiency in computer software: Microsoft Word, Excel, Powerpoint, Visio
  • Proficiency in Application Lifecycle Management, Bug tracking tools is a plus

Sterling Medical Devices (SMD) is an Equal Opportunity Employer. SMD does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.”

 

Local candidates only at this time, please. We do not offer relocation assistance.

No third-party candidates please.

Dice Id : 10112120
Position Id : 7233296
Originally Posted : 5 months ago
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