About the Organization By joining the Instant Systems team, you will be at the forefront of innovation in med tech and biotechnology. You will work with innovative companies who are leading the way in creating lifesaving therapies for patients around the world. You will work side by side with your fellow team members to create future innovations for best patient outcomes.
We are looking for strategic problem solvers who thrive in an autonomous environment of diverse and energized collaborators. If you are motivated by new challenges and opportunities for skills growth, we welcome you to apply. Your energy and expertise is valuable, spend it making a difference on a worthy mission.
The Procurement Specialist (PS) secures a reliable, compliant and cost-effective supply of materials and services for Instant Systems' single-use medical and bioprocessing products. The role owns purchasing for assigned categories, from sourcing and negotiation to purchase orders, delivery and supplier performance. Because incoming materials become part of regulated medical products, the role works closely with Quality to keep every supplier approved, controlled and audit-ready.
Responsibilities- Buy direct materials (films, resins, tubing, connectors, filters, molded parts, packaging) and indirect items and services (sterilization, lab testing, MRO, capital equipment) for assigned categories.
- Convert MRP requirements and purchase requisitions into accurate, timely purchase orders in the ERP system.
- Run RFQs and RFPs, compare bids on total cost of ownership, and recommend supplier awards.
- Expedite late orders, manage delivery schedules and resolve shortages with Planning and Production.
- Resolve invoice, pricing and receiving discrepancies with Accounts Payable and suppliers.
- Onboard new suppliers through the Approved Supplier List (ASL) process with Quality, per ISO 13485:2016 Clause 7.4 and FDA 21 CFR Part 820 purchasing controls.
- Collect and maintain supplier documents: quality certificates (e.g., ISO 13485, ISO 9001), questionnaires, quality agreements, certificates of analysis/conformance, and material compliance statements.
- Classify suppliers by risk and support supplier audits and requalification.
- Track supplier scorecards (on-time delivery, quality, responsiveness) and lead quarterly business reviews with key suppliers.
- Issue and follow up Supplier Corrective Action Requests (SCARs) with Quality for nonconforming material.
- Ensure purchase orders reference the correct drawing, specification revision and quality requirements.
- Manage supplier change notifications (e.g., resin grade, film formulation, site or process changes) and route them through change control with Quality and R&D before acceptance.
- Gather material compliance documents for customers and regulatory files: USP / Class VI, ISO 10993, TSE/BSE and animal-origin-free statements, REACH, RoHS, Prop 65, and conflict minerals declarations.
- Support internal, customer, notified body and FDA audits on purchasing records.
- Negotiate pricing, lead times, payment terms, minimum order quantities and Incoterms.
- Draft and manage supply agreements, quality agreements and blanket purchase orders with Legal and Quality.
- Deliver annual cost-savings and cost-avoidance targets through negotiation, consolidation and alternative sourcing.
- Track commodity and resin price trends and advise on buying strategy.
- Identify single-source and sole-source risks and lead second-source qualification with R&D and Quality.
- Set safety stock, reorder points and consignment or VMI programs with Planning.
- Build and maintain supply risk and business continuity plans for critical materials.
- Manage import/export documents, customs brokers and freight with Logistics.
- Keep supplier, item and pricing master data accurate in ERP.
- Report weekly on open POs, past-due deliveries, spend and savings.
- Improve purchasing procedures and work instructions under document control.
- Other responsibilities as assigned
- Bachelor's degree in Supply Chain Management, Business Administration, Engineering or a related field; OR an associate degree plus 5+ years of relevant purchasing experience.
- 3-5 years of procurement or purchasing experience in a manufacturing environment, with at least 2 years in medical devices, pharmaceutical, biotech or another FDA/ISO-regulated industry (preferred).
- working knowledge of purchasing controls under ISO 13485 and FDA 21 CFR Part 820, including approved supplier lists and supplier change…
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