Senior Quality Engineer

About the company

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 and set us apart as trusted leaders in precision medical device development and manufacturing.

Elevaris Medical Devices leverages a legacy of trust and expertise to deliver precision solutions to medical device customers. We are development and engineering experts, one of the world's leading manufacturers of made-to-spec procedural needles, and a Contract Development and Manufacturing Organization (CDMO) serving industry-leading healthcare companies, global OEMs, and emerging technology firms. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

About the role

This onsite position in Wilmington, MA, is for a Senior Quality Engineer with prior experience in the medical device industry. The role involves maintaining the supplier quality program, supporting customer complaints, performing failure investigations, managing non-conforming material, and driving continuous improvement initiatives.

Responsibilities

• Investigate, evaluate, and report adverse event incidents or device malfunctions as required by FDA and international regulatory authorities.
• Support nonconforming material (NCR) and customer complaints: perform investigations, material dispositions, and communicate with customers and/or suppliers.
• Facilitate the supplier corrective action (SCAR) subsystem: communicate with suppliers, follow up on investigations, and ensure corrective action planning and implementation.
• Support the corrective and preventive action (CAPA) subsystem: perform investigations, follow up on corrections, root cause analysis, corrective action plans, implementation, and effectiveness verification.
• Qualify new and existing suppliers, perform supplier audits, monitor supplier performance, provide scorecards, and manage related supplier activities.
• Facilitate the execution of Risk Management activities.
• Conduct Gage R&R and validations as needed.
• Identify statistically based sampling plans for inspections and testing.
• Support activities to ensure compliance with cGMP, QMSR, ISO 13485, MDD/MDR, ISO 14971, and other applicable regulations and standards.
• Participate in internal and external audits (ISO, MDD/MDR, customer, supplier) and FDA inspections.
• Support Post-Market Surveillance (PMS) activities as required.
• Collect and report Quality metrics and data.
• Identify and implement opportunities for continuous improvement.
• Perform other Quality System-related duties as required, including communicating compliance information (e.g., RoHS, conflict materials, Prop 65).
• Communicate change notices as applicable.
• Support development of control plans, validation plans, and inspection procedures for new product development projects.

Requirements

• Bachelor’s degree, preferably in Engineering, Science, or Math, or equivalent/relevant experience.
• 5+ years of Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA/ISO regulated setting.
• Knowledge of statistical sampling and analysis.
• Strong knowledge of ISO 13485, FDA QSR, ISO 14971, and EU MDR concepts and guidelines, as well as other national and international regulations and standards.
• Ability to read blueprints and interpret Geometric Dimensioning and Tolerancing (GD&T).
• Technical writing experience.
• Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (e.g., Six Sigma, Lean manufacturing).

Preferred Skills

• Sterile background.
• Excellent organizational, verbal, written communication, and problem-solving skills.
• Reliability and attention to accuracy, detail, and timeliness; strong reporting and information analysis skills.
• Able to work in a fast-paced environment and meet strict deadlines.
• Self-motivated with the ability to work with minimal supervision.
• Proficient in MS Office Suite, Visio, Project, and Minitab.

Physical Demands

The physical demands described are representative of those required to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform these functions.

• Regularly required to be independently mobile.
• Required to interact with a computer and communicate with peers, co-workers, and external partners.

Pay

$115,000 - $130,000 USD per year (Wilmington, MA).