Supplier Quality Engineer

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

Harba Solutions Inc. is seeking a Supplier Quality Engineer to ensure compliance with product and regulatory standards. This mid-senior level role involves managing supplier quality, executing audits, and collaborating with cross-functional teams to maintain high-quality service delivery. Candidates should have a relevant engineering degree and experience in quality management within the pharmaceutical or medical device industries.

Benefits

Vision insurance

401(k)

Medical insurance

Qualifications

• Minimum 2–5+ years’ experience in pharmaceutical, medical device, or automotive industry.
• Knowledge of applicable standards: ISO, cGMP, FDA, CFRs.
• Must be willing to travel domestically and internationally.

Responsibilities

• Deploy robust processes for supplier qualification and certification.
• Collaborate with Supply Chain and Operations teams.
• Conduct root cause analyses to resolve quality issues.

Skills

Supplier Selection and Qualification Processes

Quality Management System

CAPA

Auditing techniques

Education

Bachelor's degree in an engineering discipline

Job description

This range is provided by Harba Solutions Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$80,000.00/yr - $100,000.00/yr

Direct message the job poster from Harba Solutions Inc.

Stevanato Senior Recruitment Consultant - Harba Solutions

Mission

The Supplier Quality Engineer is responsible for executing activities related to the qualification and certification of suppliers, ensuring their compliance with product and process regulatory requirements, quality standards, and customer expectations. This role supports the achievement of high-quality service delivery by effectively implementing the Quality Management System, contributing to cross-functional processes, and providing expertise in supplier quality management.

Key Responsibilities

• Deploy robust, systematic processes for supplier qualification and certification.
• Serve as a single point of contact for quality issues related to suppliers.
• Collaborate with Supply Chain, Operations, and Commercial teams to provide technical feedback and reports.
• Execute quality specifications for materials, products, and services supplied.
• Participate in new product launches and validate supplier capabilities.
• Monitor supplier process changes and apply methodologies like PPAP.
• Conduct root cause analyses to resolve quality issues.
• Develop procedures and questionnaires for supplier qualification and certification.
• Support procurement in supplier selection and assessment of process capabilities and risk.
• Coordinate and perform supplier audits to evaluate service quality and compliance.
• Follow up on audit actions and the status of supplier certification.
• Analyze complaint trends, product quality data, and supplier performance.
• Propose and implement continuous improvement actions and KPIs.
• Maintain a supplier repository and related documentation.
• Ensure a consistent approach to supplier issues that is aligned with QMS standards.
• Review and update procedures with cross-functional input.
• Act as a liaison with key internal teams and external partners.
• Drive awareness and training on supplier quality topics to ensure alignment and compliance.

Requirements

• Minimum 2–5+ years’ experience in pharmaceutical, medical device, or automotive industry as a Supplier Quality Specialist/Engineer
• Bachelor's degree in an engineering discipline or a similar related degree.
• Knowledge of applicable standards: ISO, cGMP, FDA, CFRs, PMDA, ANVISA, COFEPRIS, REACH, etc.
• Supplier Selection and Qualification Processes.
• Quality Management System and Production/Technologies Knowledge.
• CAPA, Change Control, PPAP, and Auditing techniques.
• Must be willing to travel domestically and internationally on a quarterly basis.
• Travel (25%)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Engineering, and Manufacturing

• Industries

  Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Manufacturing

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Inferred from the description for this job

Vision insurance

401(k)

Medical insurance

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