Quality Engineer

Leads efforts in site quality assurance programs and improvement activities. Responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations, as well as FDA requirements. 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.

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, and the internal audit program. Works collaboratively with other departments in both a leadership and participative manner to integrate the necessary systems.

Work Schedule

1st Shift (Monday - Friday)

Major Job Duties And Responsibilities

• 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; recommends and implements activities to close gaps identified in audits to ensure compliance with applicable requirements.
• Performs internal audits at other sites and may participate in supplier audits as required.
• Responsible for maintaining Corrective and Preventive Action program activities within specific scope of responsibility to identify and implement effective corrective actions.
• 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 with and provides input to Management of Change process.
• Performs statistical evaluations for processes and trending and leads validation activity associated with new products or changes to existing processes and products.
• Works collaboratively with supplier quality personnel to identify and resolve quality-related issues impacting site performance as well as customer complaints.
• 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.
  
  

Knowledge, Skills, And Abilities

• Excellent writing and presentation skills.
• Demonstrated ability to accomplish goals through others.
• Demonstrated familiarity with chemical nomenclature and Quality Control testing and methods.
• Ability to merge divergent resources into an effective and efficient cross-functional team.
• Highly detail-oriented with demonstrated strong analytical and problem-solving skills.
• Ability to navigate in a matrixed environment and work collaboratively in a team environment.
• Excellent organization and project management skills.
• Ability to interface effectively with people at all levels of the organization, from executive to production line.
  
  

Working Conditions

The work environment is a manufacturing facility, and the appropriate PPE will be required in designated areas. Domestic travel is required on occasion.

Qualifications

• 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.
• Experience working within cGMP/ISO 9000 regulated environments required.