Sr Quality Compliance Engineer

Job Title: Sr Quality Compliance Engineer

Location: Waukegan, IL60087 onsite 5 days a week

Duration: 6-12 months

Please note that this is NOT an IT position.

We are seeking a Senior Quality Compliance Engineer with experience in a regulated environment to support quality systems, documentation, and compliance activities. The ideal candidate will have the ability to hit the ground running, focusing on documentation, CAPA management, and quality approvals rather than direct manufacturing floor work.

Key Responsibilities:

• Quality Systems & Compliance: Ensure compliance with regulatory standards by reviewing and approving documentation, batch records, and procedural updates.
• CAPA Management: Oversee and manage Corrective and Preventive Actions (CAPA), ensuring thorough documentation and timely resolution.
• Event Review & Approvals: Review quality events for completeness and compliance, facilitating approval processes as needed.
• Calibration Activities: Support and review calibration processes, ensuring compliance with industry regulations.
• Documentation & Process Updates: Maintain and update procedural Best Operating Practices (BOPs) to align with evolving regulatory requirements.
• System Expertise: Utilize Maximo for tracking calibration activities and asset management.
• Regulatory Support: Assist with audits and inspections, ensuring all quality processes meet GMP, FDA, ISO, or other applicable regulations.

Qualifications:

• Bachelor's degree in engineering, Quality, Life Sciences, or a related field (or equivalent experience).
• 10 years of experience in quality assurance, compliance, or quality systems within a regulated environment.
• Strong expertise in CAPA management, batch records, and event investigations.
• Experience with Maximo or similar asset management/calibration systems.
• Working knowledge of GMP, ISO, FDA, or other relevant regulatory frameworks.
• Excellent attention to detail and ability to work independently in a fast-paced environment.

Preferred Qualifications:

• Experience in medical devices, pharmaceuticals, or biotechnology industries.
• Prior involvement in audit preparation and regulatory inspections.
• Strong analytical and problem-solving skills with a process-improvement mindset.

About us…Sterling Engineering…we offer FULL BENEFITS! As a Sterling Engineering W2 employee on contract, you receive a Full Employee Benefits Package that includes Paid Time Off, Paid Holidays, 3 Medical plans to choose from, Dental & Vision plans, 401(k) with a match, and an Employee Stock Ownership (ESOP) plan.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.