We are seeking an experienced Supplier Quality Engineer to support supplier quality activities for components used in brain, spinal cord, and pelvic stimulation products. This role will partner with suppliers, engineering, quality, and manufacturing teams to ensure components meet quality, regulatory, and performance requirements throughout the product lifecycle.
Key Responsibilities:
Lead supplier selection, qualification, and ongoing supplier performance management.
Support component qualification activities for new and existing products.
Review supplier documentation, quality records, and component performance data.
Drive resolution of supplier quality issues through root cause analysis and corrective actions.
Conduct supplier audits and assessments to ensure compliance with GMP, regulatory, and quality standards.
Partner with New Product Development and Component Engineering teams to implement quality requirements, control plans, and inspection strategies.
Identify and implement continuous improvement opportunities to enhance supplier and product quality.
Required Qualifications:
Bachelor's degree in Engineering, Science, Quality, or a related technical field.
Minimum 4 years of relevant experience; 5+ years preferred.
Experience in a regulated industry (medical device, pharmaceutical, aerospace, automotive, etc.).Strong critical thinking, problem-solving, communication, and technical documentation skills.
Experience working directly with suppliers and component qualification activities.
Preferred Qualifications:- Medical device industry experience.
- Experience supporting New Product Development (NPD).Knowledge of GMP, FDA regulations, and ISO 13485.PPAP experience.
- Top Skills
- Regulated industry experience
- Supplier quality and component qualification expertise
- Strong communication, documentation, and problem-solving abilities
