Senior Quality Engineer

Elevaris Medical Devices•Wilmington, MA

94d•$115,000 - $130,000•Onsite

About The Position

The Senior Quality Engineer maintains and supports quality systems and supplier quality activities in a manufacturing environment. The role handles nonconforming materials, customer complaints, adverse-event and device-malfunction investigations, supplier corrective actions, CAPAs, audits, risk management, validations, and continuous improvement. The position supports compliance with applicable FDA and international regulations and quality standards, as well as post-market surveillance and new product development quality planning. This position is onsite in Wilmington, Massachusetts.

Requirements

Bachelor’s degree, preferably in Engineering, Science, or Math, or equivalent/relevant experience.
At least 5 years of Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA/ISO-regulated environment.
Knowledge of statistical sampling and analysis.
Strong knowledge of ISO 13485, FDA QSR, ISO 14971, EU MDR concepts and guidelines, and other national and international regulations and standards.
Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T).
Technical writing experience.
Experience performing quality audits and using manufacturing processes, techniques, and continuous-improvement methodologies such as Six Sigma or Lean manufacturing.
Ability to meet the role’s physical demands, including being independently mobile, using a computer, and communicating with peers, co-workers, and external partners.

Nice To Haves

Prior experience as a Senior Quality Engineer, preferably at a medical device company.
Sterile background.
Excellent organizational, verbal, written communication, and problem-solving skills.
Reliability and attention to accuracy, detail, and timeliness; reporting and analyzing information skills.
Ability to work in a fast-paced environment and meet strict deadlines.
Self-motivation and ability to work with minimal supervision.
Proficiency in MS Office suite, Visio, Project, and MiniTab.

Responsibilities

Investigate, evaluate, and report adverse-event incidents or device malfunctions as required by FDA and international regulatory authorities.
Support nonconforming material and customer complaint processes, including investigations, material dispositions, and communications with customers and suppliers.
Facilitate the supplier corrective action (SCAR) subsystem; communicate with suppliers and follow up on investigations and corrective action planning and implementation.
Support the CAPA subsystem, including investigations, corrections, root-cause investigations, corrective-action plans, implementation, and effectiveness verification plans.
Qualify new and existing suppliers, conduct supplier audits, monitor supplier performance, provide scorecards, and perform related supplier-management activities.
Facilitate risk-management activities.
Conduct Gage R&R studies and validations as needed.
Identify statistically based sampling plans for inspections and testing.
Support compliance with cGMP, QMSR, ISO 13485, MDD/MDR, ISO 14971, and other applicable regulations and standards.
Participate in internal and external audits, including ISO, MDD/MDR, customer, and supplier audits, and FDA inspections.
Support post-market surveillance (PMS) activities as required.
Collect and report quality metrics and data.
Identify and implement continuous-improvement opportunities.
Perform other quality-system duties as required, including communicating compliance information such as RoHS, conflict materials, and Prop 65 to customers or suppliers as needed.
Communicate change notices as applicable.
Support development of control plans, validation plans, and inspection procedures for new product development projects.