Supplier quality consulting for medical device and combination product companies.
Supplier audits, inspection readiness, quality agreements and M&A supplier integration from a supplier quality engineer with 15+ years in medical devices. Engagements are scoped to the need, from a single document or record review, to short projects such as audits, supplier site reviews and on-site problem solving, to fractional or full-time SQE support.
Services
Focused on supplier and purchasing controls for medical device and combination product manufacturers, under FDA QMSR (21 CFR 820), ISO 13485 and MDSAP.
Supplier audits
Qualification, surveillance and for-cause audits, including suppliers under FDA warning letters, against ISO 13485, QMSR and client-specific requirements. Conducted on site or remotely, in the US and internationally, with graded findings supported by objective evidence and a report issued within five business days.
Inspection readiness
A gap assessment of supplier controls against QMSR and ISO 13485 clause 7.4, followed by remediation: procedure revisions, risk-based justifications, supplier file updates and a mock inspection of purchasing controls ahead of FDA, notified body or MDSAP audits.
Supplier file remediation
File-by-file review of qualification basis, risk classification, evaluations, monitoring and quality agreements, using a risk-based approach to identify gaps and prioritize remediation.
Fractional and contract supplier quality
Purchasing controls support sized to your needs, covering supplier NCRs and SCARs, change notifications, supplier monitoring and the audit program, either on a set number of days per month or as a full-time contract SQE.
Quality agreements
Drafting from your template, or review and redline of a supplier's proposed agreement, covering change notification, nonconformance and CAPA, audit rights, records retention and complaint support.
M&A supplier integration
Assessment of an acquired approved supplier list and its supplier files, risk ranking for integration, integration audits, and a plan to bring the acquired supply base under your supplier controls process.
Supplier and purchasing controls program
Design and implementation of a purchasing controls system: supplier approval, monitoring, SCAR, change control and quality agreement procedures and forms, a supplier risk classification method and an approved supplier list that scales with the business.
On-site problem solving
Rapid on-site support when a supplier issue affects production or shipments, including containment, root cause investigation with the supplier, and verified corrective and preventive actions.
Manufacturing quality documents
Process flow diagrams, pFMEAs, control plans and PPAP packages; process validation (IQ/OQ/PQ) protocols and reports; inspection and sampling plans; measurement systems analysis and gage R&R; first article inspections; and operator work instructions. Prepared for you or your supplier, or reviewed before approval.
Selected experience
Representative work at medical device OEMs, contract manufacturers and clinical-stage companies.
Led and supported supplier audits in the US and Costa Rica, including M&A integration audits and suppliers under FDA warning letters.
Represented supplier controls in the front room with FDA, BSI and ISO 13485 auditors at three device manufacturers, with no supplier-control findings.
Reviewed and remediated a combination product manufacturer's supplier files and revised its supplier approval procedure ahead of an FDA pre-market inspection.
Served as the sole supplier quality engineer for venture-backed device companies, owning the approved supplier list, supplier monitoring and contract manufacturer oversight.
Drafted and redlined quality agreements with contract manufacturers and critical suppliers.
Assessed an acquired company's approved supplier list and supplier files and conducted integration audits for a large medtech OEM.
Established the first PPAP and Certified Supplier programs at a major OEM manufacturing site, and updated supplier procedures for QMSR.
Drove supplier NCR and SCAR resolution and corrective action follow-through with contract manufacturers.
Worked on the shop floor of a contract manufacturer supplying medical device OEMs, responsible for control plans, SPC and quality communication with OEM customers.
How engagements work
Each engagement is scoped in writing before work begins, with defined deliverables and a clear endpoint.
Fixed fee per deliverable
Supplier audits, gap assessments, mock inspections and quality agreements, quoted per deliverable.
Phased projects
Inspection readiness, M&A integration and program builds, scoped and quoted by phase.
Time and materials
Open-ended remediation, inspection support and ad hoc requests, billed hourly or by the day.
Monthly retainer
Fractional supplier quality support on an agreed number of days per month.
Contract
Longer-term placements, contracted directly or through your preferred staffing partner.
Subcontract audit work is welcome from audit and consulting firms.
About
Jacob Prettyman, Principal Consultant
Jacob Prettyman is a supplier quality engineer with more than 15 years in the medical device industry, spanning global OEMs, a contract manufacturer and venture-backed device companies. His work centers on supplier controls: supplier audits, qualification and monitoring, quality agreements, and preparing purchasing controls for FDA, notified body and ISO 13485 audits.
Credentials
B.S. Bioengineering, University of Illinois at Chicago
ISO 13485 QMS Lead Auditor training, BSI (2024)
QMS Lead Auditor training (ISO 9001/ISO 13485), Oriel STAT A MATRIX (2017)
ASQ Certified Quality Engineer (awarded 2015)
ASQ Certified Pharmaceutical GMP Professional (awarded 2019)
