Quality Engineer, Level II in Wilmington, Massachusetts at Spectra Medical Devices, LLC

About Elevaris Medical Devices

Tired of working at a "good" job?

At Elevaris, our goal is not to be good, it's to be extraordinary.

Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.

Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

About the role

The desired candidate will have prior experience working as a Quality Engineer, preferably working in a medical device company. Specific experience and responsibilities will include, but are not limited to, providing Quality and Compliance related support to the manufacture and distribution of medical devices in accordance with applicable medical standards and regulations (ISO 13485, 21 CFR 820, etc.).

Please note this position is onsite in Wilmington Mass.

What you'll do

ESSENTIAL FUNCTIONS/MAJOR RESPONSIBILITIES:

• Provide technical support for review and approval of customer complaint investigations
• Facilitate Non conformances and MRB activities
• Facilitate the execution of Risk Management activities
• Identify statistically based sampling plans for inspections and validations
• Support validations for new and existing products, processes, and equipment
• Ensure compliance with cGMP, QSR, ISO13485, MDD/MDR, and other applicable regulations/standards
• Participate in FDA inspections, ISO Registration and surveillance audits and customer audits
• Identify and implement opportunities for continuous improvement
• Interact and coordinate activities with other departments, external vendors, and customers
• Assist or lead in the identification and implementation of CAPA
• Aid in the implementation of the SPC control system with Manufacturing and Quality Control
• Support internal quality system audits
• Provide support necessary for supplier controls, including but not limited to supplier audits
• Participate in Post-Market Surveillance (PMS) activities as required
• Collect and report metrics and data as required
• Upholds and role-models company Values of Integrity, Invested, Inclusion and Ingenuity
• Other duties as assigned by management

Qualifications

MINIMUM REQUIREMENTS:

• Bachelor’s degree, preferably in Engineering, Science or Math
• 2-4 years’ Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA regulated environment

PREFERRED SKILLSET:

• Knowledge of statistical sampling and analysis
• Knowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standards
• Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T)
• Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e, Six Sigma, Lean manufacturing, etc.).
• Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) would be a plus
• Excellent organizational, verbal, written communication, and problem-solving skills
• Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive, and collaborative manner
• Ability to work in a fast-paced environment and to meet tight deadlines
• Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
• Ability to problem solve, and multi-task with strong attention to detail
• Proficient in MS Office Suite, Visio, and Project
• Experience working in a start-up environment