Quality Engineering & Assurance

Quality Engineer leads efforts in site quality assurance programs and improvement activities. He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements. The Senior Quality Engineer is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation.
Quality Engineer acts as the key contact working directly with customers to investigate and resolve complaints and inquiries to ensure expectations are met as well as hosting and managing customer audits, certification/surveillance audits as well as the internal audit program. Work Schedule: 1st Shift (Monday - Friday)

Leads programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements
Leads customer complaint investigations requiring direct interaction with customers as well as raw material suppliers
Manages and leads audit activities within the site including GMP, regulatory, customer and internal audits; Performs internal audits at other sites and may participate in supplier audits as required
Ensures facility cGMP compliance is maintained and identifies/implements improvement programs as required
Provides GMP and GDP training to site personnel
Leads efforts to drive improvement efforts in global metrics with specific focus on complaints and complaint response time as well as CAPAs
Works collaboratively with supplier quality personnel to identify and resolve quality related issues impacting site performance as well as customer complaint
Partners collaboratively with external customers, operations leadership, and interacts with all levels of plant operations, R&D, procurement, commercial and quality teams
Works with all departments to investigate and resolve process and product quality issues
Performs other duties as assigned with or without accommodation

Excellent writing and presentation skills
Demonstrated familiarity with chemical nomenclature and Quality Control testing and methods
Excellent organization and project management skills
The work environment is a manufacturing facility, and the appropriate PPE will be required in designated areas. Domestic travel is required on occasion.
Minimum of five (5) years of experience in quality engineering or a related role required
Experience working within pharmaceutical, biotechnology and/or chemical environments required
Bachelors Degree in chemistry or a related field required
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."