Quality Engineer

About the Role

This is a 100% onsite Senior Quality Assurance Engineer position. The core focus is on owning manufacturing investigations end-to-end, not supporting or performing QC-heavy tasks such as submittals, bench testing, or batch record review.

Responsibilities

• Lead programs and improvement activities to ensure ongoing effectiveness of the quality management system in accordance with ISO and GMP requirements.
• Lead customer complaint investigations, including direct interaction with customers and raw material suppliers.
• Manage and lead audit activities (GMP, regulatory, customer, and internal audits) and implement corrective actions to close identified gaps.
• Perform internal audits at other sites and participate in supplier audits as required.
• Maintain the Corrective and Preventive Action (CAPA) program, ensuring effective corrective actions are identified and implemented.
• Ensure facility cGMP compliance and identify/implement improvement programs.
• Provide GMP and GDP training to site personnel.
• Drive improvement efforts in global metrics, focusing on complaints, complaint response time, and CAPAs.
• Provide input to the Management of Change process.
• Perform statistical evaluations for processes and trending, and lead validation activities for new products or process changes.
• Collaborate with supplier quality personnel to resolve quality-related issues impacting site performance and customer complaints.
• Partner with external customers, operations leadership, and cross-functional teams (R&D, procurement, commercial, and quality) to investigate and resolve process and product quality issues.
• Host and manage customer audits, certification/surveillance audits, and the internal audit program.

Requirements

• 5+ years of Quality Assurance (QA, not QC) experience in GMP deviation and manufacturing investigations ownership (not "assisted with").
• CAPA management, including effectiveness checks.
• Root cause analysis using named methodologies (e.g., 5 Whys, Fishbone, FMECA).
• Customer complaint investigations; direct customer interaction preferred.
• Internal audits and ISO 9001 experience.
• Change control and validation support (process, cleaning, IQ/OQ/PQ).
• Experience in pharmaceutical or chemical manufacturing environments.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Biochemistry, Chemical Engineering, or Microbiology (preferred). Pharmacy (B.Pharm) or related science degrees will be considered with strong QA experience.
• Minimum of five (5) years of experience in quality engineering or a related role within cGMP/ISO 9000 regulated environments (pharmaceutical, biotechnology, and/or chemical).

Skills

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

Also Valued

• Hosting customer, certification, and regulatory audits.
• Statistical evaluation and process trending (SPC).
• Delivering GMP/GDP training to site personnel.
• Supplier quality collaboration.
• Experience in medical device manufacturing (secondary option).

Schedule

1st Shift (Monday - Friday).

Working Conditions

The role is based in a manufacturing facility, requiring appropriate PPE in designated areas. Occasional domestic travel is required.