PPC Technical Leader – Production & Process Controls (Medical Devices) at QvalFocus Inc.

What You’ll DoServe as the technical authority for the Production & Process Controls workstreamEstablish technical standards, methodologies, templates, and acceptance criteriaMentor and guide Workstream Leads, Subject Matter Experts (SMEs), Quality Engineers, and Record Review EngineersReview and approve: SOPs, Gap Assessments, Validation Packages, Technical Documentation, Quality EvidenceLead cross-functional initiatives involving: Production & Process Controls; Supplier & Purchasing Controls; Process Validation (IQ/OQ/PQ); Acceptance Activities; Nonconforming Product; Identification & Traceability; IMTE; Labeling & Packaging; PFMEA; Design TransferEnsure compliance with: FDA QMSR; 21 CFR Part 820; ISO 13485:2016; ISO 14971Support FDA inspections, management reviews, and inspection readinessQualifications18+ years of Medical Device Quality, Manufacturing, or Quality Systems experience6+ years leading technical teams or QMS remediation programsExpertise in: Production & Process Controls; Process Validation (IQ/OQ/PQ); FDA QMSR; 21 CFR Part 820; ISO 13485; ISO 14971; Risk ManagementPreferred ExperienceQMS Remediation or Consent Decree ProgramsSupplier Quality (APQP, PPAP, FAI, SCAR)eQMS platforms (ETQ, Veeva, MasterControl)Lean Six Sigma CertificationClass II/III Medical Devices, Diagnostics, Surgical, or Imaging productsA leading medical device organization is seeking a PPC Technical Leader to provide enterprise-level technical leadership for a major Quality Management System (QMS) remediation program.

PPC Technical Leader – Production & Process Controls (Medical Devices)

Emma

Responsibilities

Skills wanted:

Language(s) required:

About QvalFocus Inc.:

mission:

qvalfocus.com/

Admin access needed