Quality Engineer

Job Detail

Lead site validation activities, ensuring flawless equipment qualification and process validations.
Maintain Validation Master Plans and provide crucial support during IQ, OQ, and PQ stages, reviewing and implementing validation protocols and reports to uphold high standards.
Coordinate site change orders, you will assess risks to minimize impacts on processes. Close collaboration with Manufacturing Operations, QC, and Technical Support is essential in evaluating production processes and addressing quality issues efficiently.
investigate quality trends from complaints and NCRs, applying statistical techniques to identify root causes and implementing corrective actions.
Review Document Change Requests, managing risk documentation and ensuring completeness of risk control actions.

Minimum qualifications:

Bachelor’s Degree in a scientific discipline with experience in quality engineering.
Candidates should have a minimum of 5 years in a cGMP or ISO 13485 environment, demonstrating a consistent record in quality-focused industries.

Preferred qualifications:

Proficient in interpreting FDA QSR regulations, ISO 13485, and ISO 14971, with extensive experience in validation and guiding various study types, including prospective, concurrent, and retrospective studies.
Knowledgeable in statistical methods, quality control, and manufacturing operations, skilled in evaluating and resolving non-conformances, deviations, customer complaints, and CAPAs.
Intermediate to advanced computer skills, including proficiency in word processing, spreadsheets, databases, ERP systems, and electronic quality management software.
Strong interpersonal and organizational skills, both verbal and written, with a curious and adaptable approach, dedicated to teamwork and collaboration.
Focused on problem-solving, possessing skills in risk evaluation and resolution, able to ask probing questions to identify root issues and facilitate discussions for consensus.
Committed to continuous improvement, balancing control and flexibility based on risk, with strong analytical abilities for managing complex projects.
Diligent and meticulous, capable of managing multiple tasks and meeting deadlines independently.

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