Quality Engineer 3

Our client, a leading Medical Device Manufacturing Company is looking for Quality Engineer 3 and This is for an initial duration of 12 Months Contract - Covington, GA

Job Title: Quality Engineer 3

Job Id: 26-05559

Location: Covington, GA

Duration: 12 Months Contract

Position Type: Hourly Contract Position (W2 only)

Onsite - 5 Days

Technical Skills

Must Have

• 1-3 years' experience in medical device or pharmaceutical manufacturing
• 1-3 years validation experience in medical device or pharmaceutical industries

Responsibilities

Quality System Management:

• Provide engineering support to maintain a comprehensive quality management system, tailored to the distribution of medical devices and pharmaceuticals.
• Ensure systems are in line with Good Distribution Practices, ISO13485 and other relevant regulatory standards.
• Provide statistical data analysis in support of investigations and continuous improvement projects.
• Lead or participate in qualifying suppliers within calibration, validation or temperature monitoring processes.

Quality Operations Oversight:

• Monitor quality control processes in change control, temperature monitoring and validations including implementing continuous improvement strategies.

Validation and Calibration Expertise:

• Lead validation efforts for distribution equipment, processes, and software, ensuring accuracy and reliability, including IQ/OQ/PQ protocol writing, execution and approval of protocols.
• Oversee the calibration of critical instrumentation to maintain precise measurements and controls, including OOT investigations
• Manage validation vendors to ensure on time calibrations, at multiple sites, of all critical equipment.

Environmental Monitoring:

• Monitor Environmental conditions at Distribution Centers to protect product integrity.
• Implement and manage controls for temperature, humidity, and other critical parameters.
• Implement and manage shipping lane controls to ensure product integrity is safeguarded throughout the shipping process.

Audit and Compliance Readiness:

• Prepare for and support both internal and external audits.
• Address audit outcomes swiftly and effectively to maintain compliance.

Quality Incident Investigation:

• Spearhead investigations into any quality deviations, non-conformances, or customer complaints.
• Implement corrective actions to prevent recurrence and enhance quality.
• Directly participate in quality investigations, including owning those investigations to closure.
• Act as a reviewer and approver of quality investigations

Document and Change Management:

• Maintain controlled procedures within calibration, validation, environmental controls, change control and risk management.
• Ensure data from environmental controls is maintained in centralized repository.
• Manage change control processes to ensure seamless transitions and compliance.
• Lead change control process for designated sites.

Required Qualifications:

• Bachelor's degree in engineering
• 2-3 years of experience in quality engineering, within a distribution center or manufacturing of medical devices or pharmaceuticals.

Preferred Qualifications:

• Master's degree in engineering
• ASQ CQA or CQE certification
• Experience with Boards of Pharmacy, licensing, and regulatory submissions
• Experience as a designated representative with state boards of pharmacy
• 2-3 years' experience with ISO 13485, certification preferred

Skills:

• Excellent problem-solving skills with the ability to think critically and creatively.
• Experience working with ERP systems.
• Knowledge of FDA regulations and ISO standards related to medical device manufacturing.
• 2- 3 years' experience with ISO 13485, certification preferred

Qualified candidates please send your word format updated resume at the earliest to Pavan: Pavan.p@sunrisesys.com [732-395-4444].

Thank You.