Quality Control Specialist

Job Summary We are seeking a highly motivated and detail-oriented Quality Control Specialist to join our dynamic manufacturing team. In this role, you will be the cornerstone of ensuring our products meet the highest standards of quality, safety, and compliance. Your expertise will help uphold our commitment to excellence by inspecting, testing, and analyzing materials and finished goods throughout the production process. If you thrive in a fast-paced environment and are passionate about quality assurance, this is your opportunity to make a significant impact! Duties Conduct thorough quality inspections using precision measuring instruments such as calipers, micrometers, and vision inspection systems to verify product specifications. Utilize advanced quality management systems and tools like Calypso for data collection and analysis to monitor product quality trends. Perform regular quality audits in accordance with

ISO 13485, ISO

9001, and GMP standards to ensure compliance with industry regulations including FDA regulations. Coordinate measuring machine (CMM) operations to assess dimensional accuracy of manufactured parts. Implement HACCP principles for food or pharmaceutical manufacturing processes to identify hazards and ensure safety standards are met. Review and analyze inspection data to identify root causes of defects and collaborate with manufacturing teams for continuous improvement. Support internal and external quality audits by preparing documentation, conducting assessments, and verifying adherence to quality systems. Assist in maintaining compliance with

ISO 13485

(medical device quality management), CGMP (current good manufacturing practices), and other relevant standards. Participate in calibration of measurement instruments such as calipers, vision systems, and other precision tools to ensure measurement accuracy. Document non-conformances thoroughly, recommend corrective actions, and verify resolution effectiveness. Experience Proven experience in a quality control or quality assurance role within manufacturing environments, preferably in medical devices, pharmaceuticals, or food industries. Strong knowledge of

ISO 9001, ISO 13485, FDA

regulations, CGMP practices, and HACCP principles. Hands-on experience operating coordinate measuring machines (CMM), vision inspection systems, calipers, micrometers, and other precision measuring instruments. Demonstrated ability to perform detailed data analysis using QA/QC software such as Calypso or similar platforms. Familiarity with conducting quality audits and implementing corrective actions based on audit findings. Excellent attention to detail combined with strong analysis skills to identify issues early and drive improvements. Effective communication skills for documenting findings clearly and collaborating across teams to uphold quality standards. Join us as a Quality Control Specialist and become an essential part of our mission to deliver products that meet rigorous safety and quality benchmarks! Your dedication will help us maintain industry-leading standards while advancing your career in a vibrant, innovative environment.

Pay:

$55,282.11 - $70,554.80 per year

Experience:

Quality control: 1 year (Preferred)

Language:

Spanish (Preferred)

Work Location:

In person