Quality Assurance Engineer

Pinnacle Partners is recruiting for a Quality Assurance Engineer on behalf of a client in Indianapolis, Indiana. We are seeking an experienced quality professional with a strong background in FDA-regulated manufacturing who is passionate about building and improving quality systems. This role offers the opportunity to influence quality across the entire product lifecycle, partnering with Engineering, Manufacturing, Regulatory, Supply Chain, and R&D while helping shape a growing Quality Management System.

Key Responsibilities:

• Ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements for medical device manufacturing.
• Develop, implement, and maintain Quality Management System (QMS) documentation supporting product design, development, and manufacturing.
• Conduct internal and external quality audits to ensure regulatory and quality system compliance.
• Coordinate Quality Management System reviews and present quality metrics and performance data.
• Review and approve manufacturing process changes affecting product quality, including equipment and software changes.
• Participate in risk management activities including FMEA and risk analysis to identify and mitigate product risks.
• Manage non-conformances, CAPA investigations, root cause analysis, and corrective actions.
• Investigate customer complaints and collaborate with cross-functional teams to ensure timely resolution.
• Develop and maintain validation documentation, technical reports, process validation protocols, and device history records.
• Monitor quality data, identify trends, and lead continuous improvement initiatives.
• Partner with Engineering and Manufacturing to execute IQ, OQ, and PQ validation activities.
• Support supplier qualification activities, supplier audits, and Supplier Corrective Action Requests (SCARs).
• Provide training and guidance on quality systems and procedures throughout the organization.
• Ensure calibration and maintenance of quality inspection equipment.
• Support quality initiatives across new product development, manufacturing, supplier quality, and regulatory compliance.

Requirements:

• Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, Industrial, Computer, or related discipline) or equivalent experience.
• Minimum of 5 years of Quality Engineering or Quality Assurance experience in medical device or other FDA-regulated manufacturing.
• Strong knowledge of FDA regulations, including FDA 21 CFR 820 and ISO 13485.
• Experience supporting Quality Management Systems (QMS), regulatory compliance, and quality audits.
• Experience leading CAPA investigations, root cause analysis, and non-conformance resolution.
• Experience with product, process, or equipment validation (IQ/OQ/PQ).
• Strong collaboration skills with Engineering, Manufacturing, Regulatory, and Supply Chain teams.
• Excellent communication, organization, and problem-solving abilities.

Preferred:

• Experience with Master Control eQMS.
• Certified Quality Engineer (CQE) or similar quality certification.
• Experience with supplier quality management and SCAR processes.
• Knowledge of Six Sigma, Lean Manufacturing, or continuous improvement methodologies.
• Experience with statistical process control (SPC), Minitab, or other quality analysis tools.
• Ability to manage multiple projects in a fast-paced manufacturing environment.

Benefits Overview:

• Competitive salary of approximately $95,000–$103,00.
• Potential relocation assistance for qualified candidates.
• Medical, dental, and vision insurance.
• Company-paid life insurance and short-term disability.
• Long-term disability coverage.
• 401(k) with employer match.
• Health Savings Account (HSA) employer contribution.
• Wellness reimbursement up to $250 annually.
• Childcare reimbursement up to $250 annually.
• Paid vacation and merit increase opportunities.
• Opportunity to help build and improve a growing Quality Management System with significant organizational impact.