Groe Advisors Hiring for Quality Engineer at Watertown, MA Full Time

Position Summary
This position is responsible to ensure that activities throughout the product lifecycle are in compliance
with procedures, standards and regulations applicable to our products. The position independently
develops, applies, and implements methods, tools and practices to achieve product quality goals and
requirements in the engineering areas of design and development.
This is a technically focused role requiring advanced skills in analyzing information, reviewing
technical s, promoting process improvement, requirements development, risk management,
product development and production controls.

Essential Functions; Responsibilities (Other Functions May Be Assigned)
Provide hands-on support to manufacturing, including troubleshooting, implementing
manufacturability improvements, training on new products or processes, documentation
compliance, and general process improvements.
Develop, validate, document, and release manufacturing and testing processes to support new
product implementation or existing products. Ensures product quality meets requirements and
documentation is complete prior to approval.
Analyze processes and process data to identify opportunities to improve the reliability or
efficiency of operations and/or to reduce cost.
? Create and maintain Manufacturing Procedures (MPs), Test Procedures (TPs), Calibration
Procedures (CPs), and Quality Control Instructions (QCIs) that ensure products are of high
quality and meet customer requirements.
? Provides input on product requirements, acceptance criteria, traceability, process monitoring,
product evaluation, failure investigation and complaint analysis.
Drive new product development and risk management activities in accordance with US and
international standards.

Perform tests to verify and validate new products, processes, software, materials, or vendors,
as required, and document the results in Technical Documents (TD).
Generate and execute equipment validation plans (IQ/OQ/PQ). Ensure compliance with
current regulatory requirements.
Initiate and process Engineering Change Orders (ECO) and Temporary Change Orders (TCO)
per established procedure.
Participate in Material Review Board (MRB) meetings, Identify compliance gaps, lead root
cause analysis and corrective actions for non-conforming components.
Work with Suppliers and Company’s internal manufacturing to implement sustaining and cost
reduction activities.
Adhere to established procedures under Quality System.
Drive continuous product and process improvement and proactively identify and implement
best-in-class quality engineering practices.

Qualifications / Experience Requirements
BS in Engineering (Biomedical, Mechanical, Industrial, Operations), is preferred.
5+ years of experience in medical device manufacturing.
Experience working in high-volume manufacturing industry. Consumer electronics
manufacturing experience is a plus.
Proficient with dimensional inspection and test equipment.
Lean manufacturing experience is a plus.
Working experience in medical device industry with knowledge of FDA’s guidance documents
and regulations, ISO standards related to quality and medical device industry.
Thorough understanding of industry regulations: cGMP, ISO QMS standards (21CFR820,
ISO13485)
Excellent organizational, record keeping, and communication skills (verbal and written) and
ability to effectively interact with staff and management.

Job Type: Full-time

Pay: $95,000.00 – $110,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Watertown, MA: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor’s (Required)

Experience:

• FDA & ISO regulations: 1 year (Required)
• Consumer Electronics: 1 year (Preferred)
• Dimensional inspection: 2 years (Required)
• Medical Device: 2 years (Required)

Work Location: One location