QA Engineer – Compliance QMS (Maternity Leave Replacement)

Temporary position with potential for a permanent role

• Responsible for maintaining the QMS, to ensure compliance with applicable regulatory requirements and standards.

• The role provides quality oversight for key QMS processes, including CAPA, Complaint Handling, Internal Audits,, Document Control, Training Compliance, and supplier control.

• Lead, monitor and coordinate CAPA activities from initiation through closure, including use of RCA methods.

• Review, assess, monitor and process customer complaints, from the issuing to the closure.

• Plan, monitor and manage the internal audit process.

• Support supplier audits and external audit activities as required.

• Assist departments in preparing for external.

• Review quality system documents for compliance.

• Support QMS training compliance and maintenance of training records.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.

• Certified Quality Engineer and auditor (CQE, CQA) or equivalent certification.

• 3-5 years of Quality Engineering experience in the medical device industry or pharmaceutical industry.

• Experience with relevant standards (ISO13485).

• Experience supporting FDA audits, ISO 13485 audits, MDSAP audits, or notified body audits.

• Knowledge of statistical analysis.

• Experience with Internal audit performance

• Experience managing CAPA, RCA, complaints, audits, training and doc control processes.

• Experience with supplier quality management and supplier remediation programs.

• Experience with supplier audits and complaints.

• Experience with RCA methods

• Fluent English (written and spoken).

• Proficiency in MS-OFFICE