QC Lab Technician

The purpose of this role is to support the Quality Control Laboratory in ensuring product quality and regulatory compliance through precise testing, data analysis, and documentation. The role involves operating advanced mechanical testing equipment, compiling and interpreting data using statistical tools, and contributing to root cause investigations and validation activities. By

maintaining high standards of laboratory practice and collaborating within cross-functional teams, the role plays a critical part in sustaining product integrity and continuous improvement within a regulated medical device environment.

Responsibilities:

• Ensure compliance with ISO 13485 and other relevant regulatory standards and provide audit support as required.
• Participate in validation activities such as Attribute Agreement Analysis, Correlation Studies, and Gauge R&R testing.
• Support root cause investigations and contribute to testing of malfunctioning products.
• Compile and analyze data from multiple Excel spreadsheets, populating standardized templates with calculated statistical metrics including mean, maximum, and minimum values.
• Adhere to Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) in all aspects of product testing, including planning, execution, monitoring, recording, and reporting.
• Conduct product testing to support the moulding department, including mould approvals, FAI inspections, in-press repairs, and other investigations as required.
• Maintain laboratory equipment and environment to ensure safety, functionality, and readiness for internal, customer, or regulatory inspections.
• Collaborate effectively within a dynamic team to achieve project milestones and targets.
• Proactively identify and implement improvements to laboratory operations, test methods, and material flow.
• Release product in SAP and Apriso systems upon completion of testing and review requirements.
• Complete training in relevant test procedures and protocols and maintain compliance through the embecta Learning Centre (eLC).
• Ensure all work aligns with company policies, SOPs, and quality standards.

Educational Requirements and Relevant Experience:

• A third-level qualification in Engineering, Technical, or Scientific disciplines is required.
• 1–2 years of laboratory experience within the pharmaceutical, biotechnology, or medical device industries is preferred, particularly in environments where Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) are applied.
• Proficiency in Microsoft Excel, including the ability to compile and analyze data across multiple spreadsheets.

Knowledge, Skills and Abilities:

• Hands-on experience with mechanical testing equipment and tools, including vision systems (with touch probes), CT scanners, shadow graphs, and handheld measurement devices such as vernier calipers and micrometers.

embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.