Contraline is a medical device company based in Charlottesville, Virginia. We are developing the first long-lasting, non-hormonal, and reversible male contraceptive. Our mission is to improve the reproductive health of patients worldwide by commercializing state-of-the-art medical products.

Contraline is seeking a Supplier Quality Manager, who will be responsible for qualifying, auditing, and monitoring suppliers to ensure compliance with our internal procedures, quality system, and regulatory requirements for medical devices.

• Develop, implement, and oversee supplier quality processes to support Contraline’s product development and commercialization including but not limited to:

o Establish/maintain supplier & contractor requirements

o Evaluate and select potential suppliers/contractors based on their ability to meet specified requirements

o Define the type/extent of controls to be established in accordance with regulation and industry best practices

o Ensure that records are established and maintained of approved Suppliers/Contractors

o Establish and maintain documentation to ensure that Contraline is notified of material/process supplier changes and assessments of changes are appropriate

• Evaluate supplier capabilities through direct visits, technical discussions, and audits

• Establish/review/approve supplier agreements and quality agreements

• Support product transfer process to suppliers/contractors

• Drive the execution of process validation activities at supplier facilities

• Develop, review and approve all component inspection/sampling plans

• Lead the supplier audit program – planning, execution and closure of supplier audits

• Apply sound, systematic problem-solving methodologies including statistical analysis and root cause investigation techniques to identify, prioritize, communicate, and resolve quality issues

• Establish and maintain supplier Key Performance Indicators (KPIs) and the Approved Supplier List (ASL)

• Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions; Lead inter-departmental investigations for assessing and addressing quality issues with assigned suppliers.

• Act as point of contact between Contraline, its suppliers and its customers on key compliance issues related to supplier performance

• Support internal audits as required

• Represent the organization as a subject matter expert during external audits as needed

• Regularly update quality team and management

• Actively assess suppliers and supply chain to improve processes and identify deficiencies and potential need for new or secondary suppliers

• Bachelor level degree in Engineering, Technical Field, or equivalent

• 6+ years related experience in medical device, pharmaceutical or biotechnology industries required

• Demonstrated knowledge of FDA CFR 820 with emphasis on Purchasing Controls and ISO 13485 compliance

• Experience conducting supplier audits and internal audits required

• Demonstrated collaboration, negotiation, and conflict resolution skills

• Demonstrated ability to lead, champion change, and execute to meet goals

• Demonstrated expertise in purchasing controls, verification/validation, and corrective action processes in a regulated environment

• Regular travel to supplier facilities required - Travel is approximately 30%

• Must be able to travel internationally

• Familiarity with statistical processes used in regulated environments (SPC/Sampling plan generation/etc.)

• Excellent time management and organization skills, with high emphasis on attention to detail

• Advanced computer skills, including statistical/data analysis and report writing skills.

• Ability to work within a team and as an individual contributor in a fast-paced, rapidly changing environment

• ASQ certification preferred (i.e. CQE)

• ISO-13485 Lead Auditor certification or equivalent preferred