Quality Engineer

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 Brookfield, CT location.

Benefits: We offer competitive benefits including medical, dental & vision, paid leave and a 401(k) with an employer match.

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:

• Preferred: B.S. degree in Engineering, Math, Physical Science, or equivalent field.
• Minimum Experience: 5 years of experience in 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
• Formal GMP and CFR training strongly 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.
• Ability to sit at a computer terminal for an extended period.
• Moderate noise (i.e., phone calls, online meetings, computer audio)
• While performing the duties of this job, the employee may be regularly required to stand, sit, talk, hear, reach, stoop, kneel, and use hands and fingers to operate a computer, telephone, and keyboard.
• Specific vision abilities required by this job include close vision requirements due to computer work.
• Regular, predictable attendance is required.

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. Reasonable accommodation requests must be made in writing by emailing people@romtech.com.

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.