Quality Specialist I, Receiving Inspection

Biomeme, Inc.•Philadelphia, PA

10h

About The Position

Biomeme is seeking a Quality Specialist I, Receiving Inspection to be responsible for actively supporting the development, implementation and monitoring elements of the Quality Management System through the execution of Receiving Inspection. This position provides quality guidance and engages in problem solving techniques to support manufacturing operations to ensure that raw materials, Production, and Research & Development suppliers meet the quality, integrity, and efficiency standards set by the organization. This is a vital position to support manufacturing and the development of new products.

Requirements

High school diploma or equivalent plus 3+ years of receiving/incoming inspection experience in a regulated industry (medical device strongly preferred); or Associate degree in a technical field plus 1–3 years relevant experience.
Working knowledge of: GMP, GDP, ISO 13485, 21 CFR Part 820 (QSR), and ISO 14971 risk management principles as applied to incoming inspection controls.
Proficient in reading/interpretation of engineering drawings and specifications, including GD&T.
Hands-on experience operating and programming Keyence / vision measurement systems for dimensional inspection.
Proficiency with standard metrology tools: calipers, micrometers, height gages, pin/thread gages, optical comparator, Coordinate Measuring Machines (CMM)n; basic microscope use for visual inspection.
Demonstrated ability to determine acceptability against inspection criteria and to document results accurately and legibly per GDP.
Experience with sampling plans and basic statistics relevant to inspection.
Strong attention to detail, organization, and time management; effective written and verbal communication skills.
Proficiency with MS Office and experience using ERP and electronic QMS systems.
Excellent analytical and problem-solving skills.

Nice To Haves

Familiarity with SolidWorks/AutoCAD for drawing review.

Responsibilities

Perform receiving inspections (Dimensional and Visual) per approved inspection plans, drawings, and specifications using appropriate sampling plans and risk-based criteria. These inspections could be executed via calipers, micrometers, height gauges, bore gauges, and Coordinate Measuring Machines (CMM).
Operate and program Keyence measurement systems (e.g., LM-1100) to conduct and document precise dimensional inspections; create and maintain measurement protocols; verify measurement system performance; and perform basic troubleshooting.
Read and interpret engineering, blueprints, R&D drawings and specifications (including Geometric Dimensioning and Tolerancing [GD&T]) to determine inspection requirements and product acceptability; provide feedback to R&D/Quality Engineering to improve clarity.
Perform dimensional and tolerance stack-up analysis to validate manufacturability and proper component fit.
Review and verify supplier documentation (e.g., Certificates of Conformance/Analysis, material certifications, special process records, lot traceability, shelf-life/expiration, labeling/packaging requirements).
Make accept/reject decisions and accurately record results in compliance with Good Documentation Practices (GDP/ALCOA+); release conforming product and quarantine nonconforming product.
Initiate and process nonconforming material reports (NCRs), support MRB disposition, and assist with supplier corrective actions (SCARs) by providing objective evidence and clear defect documentation (photos, measurements, samples).
Collaborate with Quality Engineering and R&D to develop/maintain receiving inspection plans, work instructions, visual standards, and gaging strategies aligned with risk management files (ISO 14971).
Conduct first article inspections (FAI) for new/changed parts; support validation/qualification activities related to incoming inspection.
Perform basic measurement system analyses (gage R&R) and support calibration/maintenance activities for inspection equipment; maintain gage logs and status labels.
Execute ERP/QMS transactions for inspections, holds/releases, and documentation
Support internal/external audits for ISO 13485 and 21 CFR 820 compliance.
Maintain a safe, organized, and compliant receiving inspection area (5S, ESD controls, segregation by status).
Communicate effectively with Purchasing, Production, Supplier Quality, and R&D to resolve issues and drive continuous improvement.
Adhere to all company safety policies and procedures and ensure a clean, safe, and organized inspection area.