Quality Engineer

Solesis•Cary, NC

21d•Onsite

About The Position

The Quality Engineer develops, coordinates, and implements various activities related to the successful overall performance of the company’s Quality Management System (QMS) in support of FDA 21 CFR Parts 210, 211, 820, ISO 13485:2016, ISO 9001:2015, customer requirements, and applicable standards.

Requirements

Bachelor’s degree in one or more of the following: Life Sciences Engineering, Engineering, Quality, Physical Science required.
One (1) to two (2) years working in a regulated environment (e.g., ISO 13485:2016, ISO 9001:2105, 21 CFR Parts 810, 811, and 820)
Knowledge and Experience with Quality Management Standards, specifically ISO 13485:2016, ISO 9001:2015, FDA 21 CFR Parts 210, 211, and 820.
Detail-oriented, self-starter, and ability to work on and coordinate multiple projects/assignments.
Strong problem-solving and analytical skills, with a concentration on risk analysis.
Demonstrated project organizational skills required.
Strong written and verbal communication skills.
Demonstrated ability to participate in and/or lead cross-functional teams, ability to independently prioritize and execute projects and responsibilities.
Intermediate to advanced knowledge of MS Office Suite and statistical software (e.g., Minitab).
Knowledge of statistics, design of experiments, sampling, gage R&R, FMEA/risk management, and process control.
Excellent customer service focus and professionalism.

Responsibilities

Perform and complete investigations and Root Cause Analyses derived from Customer Complaints, CAPAs, Trending, Nonconformances, and Out of Specifications.
Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPAs within prescribed timelines.
Assists with customer complaint investigations, performs root cause analysis, and develops corrective and preventive actions as requested. Works with customers to provide required technical support and information regarding the investigation.
Develop and monitor implementation of Protocols for product evaluation as required.
Completes Supplier Corrective Action Reports (SCARS) and communicates with suppliers regarding non-conformances and supplier changes. Aids in maintaining the supplier system.
Assists with Corrective Action System, including but not limited to, administrative duties for database maintenance.
Participates in customer meetings and assists Program Management in the transition of new customer-designed products into production when requested.
Reviews/approves records pertaining to the controlled production environment (cleanroom logs, monitoring reports).
Compiles data requested for Management Review.
Supports FDA Inspections, Customer and Third-party Audits as required.
May perform internal or supplier audits.
Assists in training new or existing personnel.