Position Overview:
The Quality Engineer will focus on development of Process Validation strategies, non-conformances, MRB, CAPA’s, tracking and reporting on monthly basis and compiling and presenting data for management review, execution, and approvals of change orders.
Essential Job Functions and Responsibilities
- Core Job
- Manufacturing process sustaining (Cleanroom environment).
- Sterilization concepts and product release.
- Contractor´s management, such as external laboratories and sterilization sites.
- Quality Inspectors management.
- Supporting
- NPI’s activities from SJ Facility to MX facility by developing and executing the transfer validation strategy. (IQ, OQ or PQ)
- Change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.
- Analyzes and performs failure analysis to non-conforming products.
- Leads in the implementation of assurances, process controls, nonconformances and CAPA.
- Reviews and participates in the update/creation process FMEA’s, application FMEA’s, and risk benefit analysis for medical devices.
- Develops and prepares monthly quality trend analysis and reports.
- Interpersonal skills
- Leads, coaches, and mentors non-exempt and entry level exempt personnel.
- A self-starter, motivated and able to positively motivate others.
- Focused, target driven with a positive, can-do attitude.
- Support additional activities, as assigned.
Required Qualifications
- Bachelor's degree in engineering or technical field or equivalent experience is required.
- Minimum of 3-5 years of experience.
- Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971.
- Able to read and understand technical data.
- Competent using Microsoft Office suites.
- Strong written and verbal communication in English.
Desired Qualifications
- Good analytical, communication (both verbal and written) and presentation skills.
- Statistical analysis software a plus.
- Effective analytical, technical, and problem-solving skills.
- Ability to multi-task and manage multiple assignments in a timely manner.
- Strong analytical skills.
- Quality engineering certification, Lean Six Sigma certification.