Company Website Posting and Campus Placement Posting

Employer: Innovative Health Sciences LLC
Job Title: Lead Quality Engineer
Salary: $108,000 per year
Location: 1108 Kings Highway, Suite #4, Chester, NY 10918

Duties:

• Lead the Quality Assurance Department to ensure quality and safety by developing and implementing processes for manufacturing products that meet required specifications for quality, function, and reliability prior to delivery.

• Write and review Master Design Validation Plan and Reporting (DVP&R), ensuring the implementation of product validation activities.

• Lead and oversee corrective and preventive actions (CAPA) activities, including investigations, root cause analysis, nonconformance documentation, and implementation of corrective/preventive actions related to product, performance, process, or packaging and labeling.

• Review and approve all production, testing, and manufacturing documents, ensuring compliance with good manufacturing practices (cGMP), good clinical practices (GCP), and good documentation practices (GDP), as well as document control and change management.

• Prepare quality assurance documents, training documents, workflows, instructions, engineering changes, and standard operating procedures (SOPs).

• Perform and lead the testing activities such as installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) on samples for inspection and validation, and maintain and review all inspection records, protocols, and reports.

• Implement and oversee incoming, in-process, and outgoing inspections, including the calibration of monitoring and measuring devices.

• Review and approve all testing data, reports, training records, and statistical methodologies related to product testing and performance.

• Generate document numbers for controlled documents, review changes, and route the documents to the appropriate departments through document control software.

• Review test data reports and analyze the data using statistical process control (SPC) methods to determine product and process performance.

• Work with suppliers on product verification/validation activities, component testing, calibration equipment software validation, and supplier quality documentation.

Requirements:

• Master’s degree (or foreign equivalent) in mechanical engineering or related field; plus 3 years of experience in job offered or as a quality engineer in the medical devices manufacturing industry.

• Knowledge of QMS ISO 13485 and FDA standards, cGMP, GDP, SPC tools, and Six Sigma.

• Experience in product testing, validation/verification activities, data analysis, equipment validations, and supplier quality management.

Apply: Email resume to syoungren@innohealthsci.com