Quality Compliance Engineer

General Summary of the Position

The Quality Compliance Engineer is responsible for maintaining and improving the effectiveness of the Quality Management System (QMS) while ensuring compliance with applicable regulatory requirements, quality standards, and internal procedures. This position owns the Supplier Management program and works cross-functionally with Operations, Engineering, Regulatory Affairs, Manufacturing, and Supply Chain to ensure suppliers, products, and processes consistently meet established quality and regulatory requirements. The role also supports internal, external, and supplier audits; corrective and preventive action; post-market surveillance; recalls and market withdrawals; clinical evaluation reports; risk management; quality metrics; and continuous improvement activities.

Essential Functions

(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills, and other characteristics. This list of tasks is not a comprehensive listing of all functions and tasks performed by this position. It does not imply that this position performs all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

• Must be able to use office equipment including, but not limited to, phone, copier, and computer.
• May be required to lift items up to 15 pounds in weight.
• Must be able to sit for extended periods of time at a desk.
• May be required to travel periodically for supplier audits and other business needs.

Knowledge, Skills, and Abilities

Supplier Management

• Maintain Supplier Management Program. Including supplier evaluation, qualification, approval, monitoring, re-evaluation, and record maintenance using a risk-based approach.
• Oversee supplier audits including planning, execution, documentation, and CAPA lifecycle.
• Maintain supplier qualification records, quality agreements, certifications, etc.
• Manage supplier change notifications and second source qualifications.
• Monitor supplier quality and performance, prepare supplier performance and re-evaluation summaries for the Supplier Qualification Team and Management Review, as applicable.

Audits

• Conduct internal, external and supplier audits, including preparation, reporting, and closure.
• Maintain auditor qualifications and audit documentation.

Corrective and Preventive Action (CAPA)

• Lead or support investigations involving CAPAs, audit findings, supplier issues, complaints, and other quality events.
• Facilitate cross functional root cause analysis and risk-based CAPA actions using quality tools.
• Drive organizational CAPA accountability through timely completion and VOE.

Complaint Management, Post Market and Performance Surveillance

• Lead complaint intake, assessment, cross functional investigations, documentation, and closure.
• Analyze complaints, clinical, regulatory, and product performance data for recurring issues, emerging risks, trends, regulatory, escalations, and corrective action triggers.
• Collaborate on Regulatory reporting and regulatory responses where applicable.
• Maintain post-market surveillance plans and reports, including Post Market Surveillance Reports, Periodic Safety Update Reports, and Summary Reports, as applicable.
• Ensure post-market information is incorporated into risk management, CAPA, and Management Review activities when required.
• Maintain clinical evaluation plans and reports.

Recalls and Market Withdrawals

• Contribute to the assessment, execution, documentation, and regulatory follow-up of recalls and market withdrawals, performing assigned tasks where applicable.

QMS Support, Maintenance and Improvement Functions

• Maintain and improve assigned QMS processes, procedures, and records.
• Support document and record control, training, change control, gap assessments, risk management, and electronic quality system validation, as assigned.
• Develop, analyze, and report quality metrics, objectives, and key performance indicators.
• Provide quality and compliance guidance for supplier, product, process, and system changes.
• Use quality data and risk-based methods to identify risks and improvement opportunities.
• Collaborate with Operations, Engineering, Manufacturing, Supply Chain, Regulatory Affairs, and CMs to improve compliance, efficiency, supplier performance, and product quality.
• Support compliance with ISO 13485, applicable FDA quality system requirements, and other applicable regulations and standards.

Core Competencies

• Strong knowledge of QMS and regulated-industry compliance requirements.
• Working knowledge of supplier qualification, supplier monitoring, supplier auditing, supplier corrective action, and quality agreements.
• Ability to apply risk-based thinking, root cause analysis, and quality engineering principles.
• Ability to analyze data, identify trends, and communicate conclusions clearly.
• Strong written communication, technical writing, organization, project management, and follow-up skills.
• Ability to manage multiple priorities and work independently while maintaining attention to detail.
• Ability to collaborate effectively with Operations, Engineering, Manufacturing, Supply Chain, Regulatory Affairs, and other functions.
• Ability to travel periodically for supplier audits or other business needs.

Education, Training, and Experience

Required

• Degree, in technical/scientific sciences and 2 years' experience in regulated industry
• Or 5 years' experience in medical device manufacturing environment, minimum of 3 years' experience in Quality role
• Or 8 years in a regulated industry environment. minimum of 4 years in a Quality role.

Preferred

• Experience conducting internal or supplier audits.
• Experience applying ISO 13485, QMSR, EU MDR and/or MDSAP
• Experience with CAPA, change control, complaint handling, supplier management, or risk management.
• Professional quality or auditing certification, such as ISO 13485 Lead Auditor, ASQ CQE, CQA, or equivalent, Lean Six Sigma.