Senior Supplier Quality Engineer

Tactilemedical; Minneapolis (MN); On-site; USD 93,600 - 131,040; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Retirement benefits

Paid time off

Parental leave

Job summary

Tactile Medical is looking for a Senior Supplier Quality Engineer to manage supplier quality and compliance. This role involves conducting audits, ensuring regulatory adherence, and monitoring supplier performance. The candidate should have significant experience in supplier quality management, preferably in the medical device industry.

Key qualifications include a Bachelor's degree and at least 5 years of relevant experience. The position offers a competitive salary and a comprehensive benefits package including health insurance and paid time off.

Qualifications

• 5+ years of experience in supplier quality management or quality assurance.
• Experience with ISO 13485 and FDA QSR regulations.
• Lead auditor certification through an accredited organization.

Responsibilities

• Manage and ensure quality and compliance of suppliers.
• Conduct supplier audits to confirm adherence to standards.
• Track supplier performance metrics and recommend corrective actions.

Skills

Supplier quality management processes

Conducting supplier audits

Problem-solving skills

Analytical mindset

Communication skills

Education

Bachelor’s Degree or equivalent

Tools

Netsuite or other ERP Software

Grand Avenue Software

Job description

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.

The Senior Supplier Quality Engineer is responsible for managing and ensuring the quality and compliance of suppliers. The Senior Supplier Quality Engineer will conduct supplier audits, maintain the Approved Supplier List (ASL), monitor supplier performance through metrics, and oversee supplier-related quality activities to ensure that all products and materials meet regulatory requirements and internal quality standards. Must be able to demonstrate understanding of medical device regulations (ISO 13485, 21 CFR 820, etc.).

Accountabilities & Responsibilities

• Develop and maintain quality systems, processes, and procedures related to supplier quality management.
• Plan, schedule, and perform regular supplier audits to ensure compliance with company quality standards, regulatory requirements (e.g., ISO 13485, FDA), and contract specifications.
• Manage the supplier corrective action system by reviewing and prioritizing SCAR requests for completeness, coordinating SCAR tasks as appropriate, and compiling SCAR metrics for reporting.
• Track and analyze supplier performance using established metrics. Report on supplier performance to management, recommending corrective actions when necessary.
• Oversee and manage the ASL, ensuring that all suppliers are properly evaluated and qualified according to regulatory and company standards. Review and approve new suppliers, re-qualify existing suppliers, and ensure the timely update of supplier records.
• Maintain accurate documentation related to supplier qualifications, audits, corrective actions, and performance metrics.
• Support the Supplier Management process in electronic Quality Management System by performing administrative tasks such as coordinating supplier change evaluations, maintaining current supplier information, and recording results of metrics review.
• Ensure supplier evaluation and monitoring processes meet quality system requirements and company policies.
• Maintain and support administrative functions in quality management system software supplier modules as necessary.
• Other duties as assigned.

Education & Experience

Required:

• Bachelor’s Degree or an equivalent combination of education and work experience.
• 5+ years of experience in supplier quality management, supplier audits, or quality assurance, preferably within the medical device or regulated manufacturing industries.
• Experience with ISO 13485, FDA QSR, and other regulatory requirements for medical devices.
• Lead auditor certification through an accredited organization (e.g. ASQ, notified body, etc.).
• Ability to travel to supplier locations for audits and assessments (approximately 20% of the time) including internationally.

Preferred:

• Proficiency with Netsuite or other ERP Software.
• Experience with Grand Avenue Software.
• CSQP or related certification.
• Six Sigma belt certification.

Knowledge & Skills

• Strong knowledge of supplier quality management processes and best practices.
• Proven ability to conduct supplier audits and assess supplier performance.
• Analytical mindset with strong problem-solving skills and attention to detail.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Strong written and verbal communication skills, with the ability to influence and drive improvements.
• Knowledge of medical device regulations (21CFR820, ISO 13485).

Compensation

US Pay Range

• $93,600 — $131,040 USD

Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.