Quality Engineer

2 days ago

Brookfield, United States ROM Technologies, Inc. Full time

About Our Company:

ROMTech is a medical technology company that has created and patented a revolutionary medical device and telemedical platform which delivers in-home rehabilitative care. Our disruptive technology has proven to yield faster recoveries and better outcomes with unmatched patient compliance. We began in orthopedics and have entered scale-up of our orthopedic business. We are now leveraging our core technology, infrastructure, and first mover position to enter cardiology, followed by other adjacent markets. Having created this new lane, we have a unique opportunity to serve as the global leader in the business, technology, and science of recovery, and to bring life-changing help to many millions of people.

Benefits: We offer competitive benefits including; medical, dental & vision. Generous PTO and 401(k) with an employer match.

Position Overview:

ROMTech is seeking an experienced Quality Engineer to join our dynamic Quality/Regulatory team. The Quality Engineer will report directly to the Director of Quality. They will support the execution of the design and development for new products and support sustaining activities for our existing legacy products. This is a full-time position based at our headquarters in Brookfield, CT.

Responsibilities:

  • Design and review project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
  • Work with the Design, Development Engineering, Technical Sourcing, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs.
  • Audit, monitor, and witness test processes for compliance with requirements and keeping a watchful eye for risk opportunities.
  • Ability to participate in gathering of QA Engineering metrics gathering and compiling for higher level review.
  • Communicate regularly with Manufacturing and Test counterparts, and proactively engage in issue resolution.
  • Other responsibilities as assigned.

Requirements:

  • 3-5 years of experience working within the Medical Device Industry.
  • Strong knowledge of 21 CFR Part 820 (CGMP).
  • Strong knowledge of quality management systems and manufacturing processes.
  • Strong experience with risk management (ISO 14971).
  • Experience with Design Verification & Validation, preferred.
  • Strong multi-tasking and prioritization skills.
  • Strong technical writing ability- At a level sufficient to complete Design History File documentation (test protocols, test reports).
  • Strong aptitude with spreadsheet utilization (pivot tables, data analysis and reporting).
  • Problem-solving, assertiveness.
  • Ability to thrive in a fast-paced environment.
  • Excellent interpersonal and communication skills.

If this sounds like an exciting opportunity to embark in the next chapter of your career, please respond and include an up-to-date resume.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand for extended periods of time, walk, crouch and lift and/or move up to 80 pounds and use hands to operate a computer and other office equipment. The employee is frequently required to reach with hands and arms, talk, and hear. Specific vision abilities required by this job include close vision and the ability to adjust focus.

We are an equal opportunity employer. Qualified Applicants are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, national origin, age, genetic information, military or veteran status, sexual orientation, marital status, or any other classification protected under applicable Federal, State or Local law.

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