Senior Quality Engineer

Elevaris Medical Devices•Wilmington, MA

6d•$115,000 - $130,000•Onsite

About The Position

The desired candidate will have prior experience as a Senior Quality Engineer, preferably working in a medical device company. Specific experience and responsibilities include but are not limited to maintaining the supplier quality program (agreements, performance etc.), Supporting Customer Complaints; performing failure investigations; supporting Non-Conforming Material; managing corrective and preventive actions; supporting the internal audit program, execution of Gage R&R and validations and driving a continuous improvement program. Please note this position is onsite in Wilmington Mass.

Requirements

Bachelor’s degree preferably in Engineering, Science or Math or equivalent/relevant experience
5+ years’ Quality Engineering 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 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 Tolerances (GD&T)
Technical writing experience
Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e., Six Sigma, Lean manufacturing, etc.).

Nice To Haves

Sterile background a plus
Excellent organizational, verbal, written communication and problem-solving skills
Reliability and attention to accuracy, detail, and timeliness; reporting and analyzing information skills
Able to work in a fast-paced environment and meet strict deadlines
Self-motivated and can work with minimal supervision
Proficient in MS Office suite, Visio, Project and MiniTab

Responsibilities

Investigation, evaluation and reporting of adverse event incidents or device malfunctions as required by FDA and international regulatory authorities
Provide support of nonconforming material (NCR) and customer complaints, perform investigations, material dispositions, and communicate with customers and/or suppliers.
Facilitate supplier corrective action (SCAR) subsystem, communicate with suppliers, and follow up on investigations and corrective action planning and implementation by suppliers
Support corrective and preventive action (CAPA) subsystem, perform investigations, follow up on corrections, root cause investigations, corrective action plan, implementation, and effectiveness verification plan
Perform the qualification of new and existing suppliers, perform supplier audits, monitor supplier performance provide scorecards, and other related supplier management 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, QSR, ISO 13485, MDD/ MDR, ISO 14971 and other applicable regulations and/or standards
Participate in internal and external (ISO, MDD/MDR, customer, supplier) audits and FDA inspections
Support Post-Market Surveillance (PMS) activities as required
Collect and report Quality metrics and data as required
Identify and implement opportunities for continuous improvement
Perform other Quality System related duties as required communicate with customers and or suppliers as needed providing compliance information i.e., RoHS, conflict materials, prop 65 etc. as needed.
Communication of change notices as applicable