Employment Type: Full-Time
About Ensera
Ensera is a global contract manufacturer and packaging partner to the medical device, pharmaceutical, and allied healthcare sectors. We deliver high‑quality, customized solutions that improve patient care and operational efficiency. With a strong international presence and a commitment to innovation, sustainability, and people, Ensera continues to invest in talent, technology, and responsible operations.
Role Purpose
The Senior Quality Engineer provides leadership and oversight for quality activities supporting pharmaceutical secondary packaging and medical device contract manufacturing operations. This role ensures compliance with applicable FDA regulations, internal procedures, and customer requirements while driving continuous improvement within the Quality Management System.
The Senior Quality Engineer partners cross-functionally to maintain GMP compliance, supports audits and regulatory inspections, and plays a key role in ensuring the consistent execution of quality processes across operations.
Duties & Responsibilities
GMP Quality Oversight & Operations
· Provide day-to-day quality oversight for operations to ensure compliance with applicable FDA regulations, including 21 CFR Parts 210, 211, and 820, internal procedures, and customer requirements.
· Ensure packaging activities, inspections, and material release activities are performed in accordance with approved procedures, specifications, and the Quality Management System.
· Support and, when necessary, perform on-floor quality oversight activities to maintain effective GMP control during operations.
· Assist with external Technical Visits as requested.
Batch Record Review & Product Disposition
· Support review and approve executed packaging batch records for accuracy, completeness, and GMP compliance.
· Ensure all deviations, discrepancies, and investigations impacting batch disposition are adequately resolved prior to product release.
· Support material disposition decisions in accordance with approved procedures and quality system requirements.
Deviations, Investigations & CAPA
· Own and manage deviation, nonconformance, and investigation processes.
· Lead root cause analysis and development, implementation, and effectiveness verification of corrective and preventive actions (CAPAs).
· Trend quality events and identify opportunities for continuous improvement.
Audit & Inspection Support
· Supports Quality Management Representative during customer audits and regulatory inspections.
· Prepare audit materials, present quality systems and records, and support responses to audit observations in coordination with Quality leadership.
· Support internal audits and periodic quality system reviews as required.
Quality System Implementation & Continuous Improvement
· Implement and maintain quality system processes supporting operations, including documentation control, change management, training, and risk management activities.
· Drive continuous improvement initiatives to strengthen GMP compliance, documentation quality, and operational effectiveness.
· Monitor and report quality performance metrics related to operations.
People Leadership & Development
· Directly supervise, train, and develop GMP Quality Associates.
· Ensure personnel are trained and qualified to perform assigned GMP quality activities.
· Provide coaching and performance feedback to support consistent quality execution.
Cross-Functional Collaboration
· Partner with Manufacturing, Engineering, Warehouse, Regulatory Affairs, and other functional teams to resolve quality issues and support compliant operations.
· Support customer communications related to assigned quality matters.
Qualifications and Educational Requirements
· Bachelor’s degree in a scientific, technical, or quality-related discipline (e.g., Chemistry, Biology, Engineering, Quality Management) required, advanced degree preferred.
· Minimum 5–8 years of progressive quality and hands-on experience in a regulated manufacturing environment, with demonstrated experience supporting pharmaceutical, pharmaceutical packaging or medical devices operations.
· Strong working knowledge of FDA cGMP requirements, including 21 CFR Parts 210, 211 and/or 820.
· Demonstrated experience reviewing and approving batch records, managing deviations and investigations, and leading CAPA activities in a GMP environment.
· Experience with supporting Quality Management representative during customer audits and regulatory inspections.
· Prior people management or supervisory experience, including training and development of quality personnel.
· Proficient in the use of computers and standard business software, including Microsoft Office applications (Word, Excel, Outlook); experience with electronic quality management systems preferred.
· Strong understanding of Good Documentation Practices (GDP) and risk-based quality principles.
· Ability to read, write, and communicate effectively in English to prepare, review, and approve GMP documentation, batch records, investigations, CAPAs, and audit responses.