Description:
Minimum of 3 to 5 years related Quality Inspection experience in Medical Manufacturing environment.
Medical device History checking experience
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
Perform detailed reviews of Device History Records (DHRs) as part of final inspection and release activities for finished products, ensuring accuracy and compliance with documentation standards.
Conduct reviews of manufacturing records for replacement components, subassemblies, and in-process inspections to ensure alignment with quality requirements. Support manufacturing personnel by ensuring proper documentation of Failure Investigation Reports and processing of Non-Conforming Materials in the Product Lifecycle Management (PLM) system, including identification, quarantine, and documentation.
Perform routine inspections, including field service and special inspections, to support validations, studies, and incoming inspection activities.
Communicate and reinforce Good Manufacturing Practices (GMP) to manufacturing personnel to uphold quality standards.
Review and provide input on new releases of Inspection and Test documents to ensure adherence to Good Documentation Practices (GDP).
Maintain QA Activity Collection Plans, First Pass Yield reports, and other applicable tracking mechanisms to monitor quality metrics.
Collaborate with Engineering to provide feedback on documentation improvements and process changes.
Support Incoming, product returns and calibration teams as needed as needed.
Perform other duties as assigned by leadership to meet organizational and operational needs.
Excellence through Integrity, Compliance, Safety and Environment
Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP).
Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation.
Actively contributes to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork.
Engage in continuous improvement initiatives, striving for operational excellence and efficiency.
Promote sustainable practices within the workplace, including waste reduction, recycling, and energy conservation.
Participate as applicable in workshops, training sessions, and other activities aimed at fostering a culture of continuous improvement and lean thinking.
Participate in regular training and complete all training on time.
Qualifications
Education
High school degree and/or an equivalent technical school education preferred.
Experience
Minimum of 3 to 5 years related Quality Inspection experience in Medical Manufacturing environment.
Experience with Oracle, and Agile preferred.
Skills
Strong attention to detail and accuracy in reviewing documentation and inspection processes.
Ability to work independently with minimal supervision and make informed decisions.
Excellent interpersonal and communication skills for effective collaboration across teams.
Thorough understanding and application of Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
Familiarity with quality management systems (QMS) and regulatory requirements in the medical device industry.
Ability to interpret engineering drawings, specifications, and technical documentation.
Proficient in using quality tools, metrics, and software systems, including Oracle and Agile (preferred).
Organizational skills to maintain accurate records, logs, and reports.
Commitment to continuous improvement and fostering a culture of operational excellence..
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Please rank your preferred top 3 skill sets: (For Example: tools, previous experience, technologies):
1: Knowledge of Quality Documents and processes
2: Attention to detail
3: Reliability
Must have skills: Knowledge of Quality Documents and processes
Teachable skills: Computer
Optional skills:
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