QA Engineer Operations

Quality Engineer- Operations

Location- Deerfield Beach Florida

SHL Medical is a world-leading provider in the design development and manufacturing of advanced self-injection devices. With a global team of 6000 employees we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors pen injectors and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018 with key operations in Sweden Taiwan and the US we are united by a commitment to innovation impact and growth. Together we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive inclusive and dynamic workplace for our colleagues.

Job Overview

Reporting to the Quality Assurance Manager this role provides Quality Assurance oversight of GMP operations to ensure that products are consistently manufactured in a state of control fit for their intended use and compliant with cGMP requirements and applicable regulatory filings.

The QA Engineer supports quality operations within the manufacturing areas and works collaboratively with Process Development (MS/AS) Operations and Quality Control. Responsibilities include oversight of manufacturing activities to ensure compliance with GMP requirements related to the manufacturing environment product testing equipment readiness plant hygiene process validation personnel training and material and process addition this role is responsible for the application of Quality Risk Management principles to identify assess control and mitigate risks to product quality and patient safety. The QA Engineer lead and/or support Investigation related to deviations nonconformances and atypical events ensuring robust root cause analysis appropriate CAPA and measurable effectiveness.

Main Responsibilities

• Provide Quality Assurance oversight of GMP manufacturing operations to ensure ongoing compliance with cGMP regulatory filings internal procedures and applicable standards (e.g. FDA QSR ISO 13485).
• Support daytoday quality operations within manufacturing areas including realtime floor support and review of activities impacting product quality.
• Apply Quality Risk Management (QRM) principles in accordance with ICH Q9 / ISO 14971 to identify assess control and mitigate risks to product quality and patient safety.
• Support Design Transfer activities by providing quality oversight during the transfer of products and processes from development to commercial manufacturing including review and approval of transfer documentation risk assessments validation strategies and readiness assessments.
• Participate in crossfunctional Design Transfer and Customer Project teams to ensure quality requirements regulatory commitments and customer expectations are effectively integrated into manufacturing operations.
• Review approve and support investigations related to deviations nonconformances and atypical events ensuring timely root cause analysis and effective corrective and preventive actions (CAPA).
• Collaborate with Process Development (MS/AS) Operations Quality Control and Engineering to maintain a state of control across manufacturing processes equipment and systems.
• Provide quality oversight for process validation including protocol review execution support data evaluation and final reporting.
• Ensure compliance and readiness of manufacturing equipment facilities and utilities through support of qualification validation change control and maintenance activities.
• Monitor compliance of the manufacturing environment including plant hygiene contamination control practices material flow and personnel behaviours.
• Review batch record documentation test results and release documentation to ensure accuracy completeness and compliance with regulatory and quality system requirements.
• Perform and/or support QA batch disposition decisions (release rejection quarantine) based on documented evidence investigation outcomes and risk-based justification.
• Ensure adherence to data integrity principles (ALCOA) and compliance with electronic records requirements (e.g. 21 CFR-Part 11) across all GMP training compliance by reviewing training requirements assessing effectiveness and ensuring personnel are qualified to perform assigned GMP activities.
• Participate in internal audits customer audits and regulatory inspections including inspection readiness activities and development of timely compliant responses.
• Support customerspecific quality activities including project execution technical discussions issue resolution and customer communications related to quality and compliance.
• Promote continuous improvement and a strong quality culture by identifying opportunities to enhance process robustness compliance and operational effectiveness.

Skills and Qualification

• Bachelors degree in Engineering Life Sciences or a related technical discipline; advanced degree preferred.
• Minimum of 58 years of progressive Quality Assurance experience in a GMP regulated manufacturing environment preferably within medical devices combination products pharmaceuticals or biologics.
• Demonstrated experience providing on the floor Quality oversight of manufacturing operations including assembly inspection packaging and testing activities.
• Proven experience performing batch record review and approval including electronic and paper batch records ensuring compliance with approved procedures specifications and regulatory requirements.
• Hands on experience supporting product disposition decisions (release rejection or quarantine) based on documented evidence investigation outcomes and risk based justification.
• Practical experience applying Quality Risk Management (QRM) principles to manufacturing operations investigations and change activities in alignment with ICH Q9 and/or ISO 14971.
• Strong working knowledge of cGMP regulations and quality standards including FDA QSR / 21 CFR Partsand applicable ISO standards (e.g. ISO 13485).

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings including but not limited to a drug test employment verification reference checks and a criminal background check.

For more information on SHL Medical please visit: