Quality Control Supervisor

IntePros is currently looking for a Quality Control Supervisor to join one of our growing medica device clients in Conshohocken, PA. The Quality Control Supervisor leads the quality inspection team. This position coordinates and performs quality control processes; executes sound quality policies to ensure safety and quality of products; and performs other related duties as required.Quality Control Supervisor Responsibilities:Author and revise procedures/controlled documents according to FDA, AATB, and other applicable regulationsSupport development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practicesAssures adequate sampling plans and inspection procedures are implementedMaintains quality indicators and respective reports/ presentationsAssist with deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigationsOversee incoming inspection of HCT/Ps and medical devices in accordance with standard operating procedures and regulatory/accrediting agency requirementsSort and segregate acceptable and unacceptable HCT/P products and/or medical devicesManage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspectionsAssist with training of processes and corrective actions relating to qualityOversee the product release to ensure that safe and effective product is distributed to customersResponsible for approval or rejection of components, finished products, and documents to achieve this purposeDirects the activities of the Quality Control teamOwner of process controls and non-conforming productMaintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating proceduresManage direct reportsProvide constructive feedback and guidance to develop leadership in direct reports and department managementEstablish and monitor objective annual goals for direct reportsConduct performance reviews and establish performance improvement plans as neededRecruit, interview, and select personnel for hireMaintain acceptable attendance and punctuality for scheduled work hours and meetingsEnsure completion of assigned tasks and responsibilities within defined timeframesFlexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessaryPerform other duties as assignedQuality Controls Supervisor Skills:Ability to analyze information and act on resultsAbility to work well with people at all levels within the organizationAccuracy and attention to detailAbility to secure and maintain a favorable background investigation and clearanceQuality Controls Supervisor Qualifications:A minimum of a bachelor's degree in science, engineering, other relevant discipline; minimum of 3 years' experience working in an FDA or ISO regulated environment; or equivalent combination of education and experienceA minimum of 3 years of supervisory experience or equivalentClearance of favorable background investigation required

Created: 2025-10-05