Manufacturing Quality Engineer

Description

Scope of Position:This role focuses on product quality and process integrity across the manufacturing lifecycle, supportingboth new product development and ongoing production. The Manufacturing Quality Engineer ensuresthat all products are designed, manufactured, and distributed in compliance with regulatory andcustomer requirements.
Key Responsibilities:

• Maintain and improve the Quality Management System (QMS) in alignment with ISO 13485, FDA QSR, and internal procedures.
• Process mapping, FMEAs, and statistical assessments
• Support production teams in resolving quality issues, identifying root causes, and implementing corrective and preventive actions.
• Evaluate, monitor, and improve manufacturing processes using statistical tools (SPC, DOE, MSA) to support data-driven decision-making.
• Lead and support audits (internal & external), and regulatory inspections.
• Analyze existing inspection plans, sampling plans, and quality control documentation. Make improvements where necessary.
• Assist Business Development and Engineering teams in developing inspection and sampling plans for new products.
• Participate in design reviews, ensuring compliance with Design Development requirements.
• Support verification and validation (V&V) activities, including test method validation.
• Assist with evaluation of suppliers; maintain supplier performance metrics.
• Drive supplier corrective actions and continuous improvement initiatives.
• Analyze quality data to identify trends, process capability, and improvement opportunities.
• Use Excel for statistical analysis.
• Assist with quality system elements such as CAPA, NCRs, complaint handling, and document control.
• Prepare quality reports for management, including KPIs, audit findings, and CAPA status.

Requirements

Qualifications:

• Bachelor’s degree in engineering (Mechanical, Biomedical, Industrial, or related field).
• Experience working in a regulated manufacturing environment.
• Experience with CAPA, root cause analysis tools (5 Whys, Fishbone), and process validation (IQ/OQ/PQ).
• Proficiency with statistical analysis and quality tools.

Desired Skills & Abilities:

• Strong analytical and problem-solving skills.
• Working knowledge in a regulated manufacturing environment.
• Familiar with GDT and tolerancing analysis.
• Ability to interpret engineering drawings and specifications.
• Excellent communication and cross-functional collaboration.
• Detail-oriented mindset with a commitment to product safety and compliance.
• ASQ certifications (CQE, CQA) are a plus.
• Ability to manage multiple priorities in a fast-paced environment.