Supplier Quality Specialist

Basic Qualifications

· Bachelor degree in science, math or related discipline

· 3-5 years experience in quality assurance or supplier quality, GMP environment preferred

· Min. 2 years experience in supplier interfacing role

· Knowledge cGMP Guidelines and regulatory requirements.

· Detail oriented, and ability to work with others in a multidisciplinary team environment.

· Ability to travel independently (<5%)

· Experience with quality management systems (QMS), such as electronic document control and CAPA systems.

· Proficiency in quality methodologies and tools, including Root Cause Analysis, Statistical Process Control (SPC), and Failure Mode and Effects Analysis (FMEA).

· Strong analytical, problem-solving, and decision-making abilities.

· Excellent written and verbal communication and interpersonal skills.

· Demonstrated ability to manage multiple projects simultaneously and prioritize tasks effectively.

· Strong attention to detail.

· Ability to travel to supplier locations as needed.

· ASQ certification (e.g., Certified Quality Engineer or Certified Quality Auditor) preferred.

· Strong time management / project management capabilities

· Strong analytical and written and oral communication skills

· Working knowledge of Process / Manufacturing applications.

Responsibilities:

· Conduct supplier evaluation and risk assessments including on-site quality audits as required to ensure conformance to Supplier Quality System requirements. Work to identify and resolve potential problems and continually improve the process for qualification and evaluation of new and existing suppliers, specifications, components, and materials.

· Analyze audit results to develop, prioritize and execute corrective actions and supplier development action plans to continually improve supplier performance.

· Collaborate with procurement to ensure appropriate supplier selection and to communicate performance expectations.

· Ensure closure of Supplier NC’s and CAPA’s, to confirm comprehension, development, and execution of corrective/preventive action with regards to any nonconformity cited.

· Plan, schedule, and conduct regular on-site and remote supplier audits to ensure compliance with quality systems and GMP regulations.

· Present findings from audits and assessments to management.

· Cooperatively with Purchasing monitor and track supplier performance using key performance indicators (KPIs) such as defect rates, on-time delivery, and responsiveness.

· Provide regular status reports on supplier performance to management and cross-functional teams.

· Enhance supplier scorecard and metrics to improve quality of the product and process with measurable KPIs

· Act as the key interface with site operations as it pertains to Supplier Quality Issues.

· Draft and review quality Agreements with suppliers that define responsibilities for GMP activities.

· Review and approve supplier-provided documentation, including specifications, test methods, and validation protocols.

· Ensure that all supplier-related documentation (e.g., change controls, deviations, CAPAs) is followed and closed within defined timelines.

· Manage supplier notifications of change and assess potential impact on internal processes and products.

· Maintain the supplier quality management program in a state of audit readiness for inspections by regulatory agencies.

· Perform other duties as assigned.

Job Type: Full-time

Pay: $65,000.00 - $70,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Experience:

• quality assurance or supplier quality, GMP environment : 3 years (Required)
• Root Cause Analysis, Statistical Process Control (SPC: 3 years (Required)
• Failure Mode and Effects Analysis (FMEA).: 3 years (Preferred)

Ability to Commute:

• Jackson, WI 53037 (Required)

Work Location: In person