This is a Temporary position - Approx. 3 Months with possible extensions.
The Senior Quality Control (QC) Technical Specialist reports to the Manufacturing Quality Engineer Lead or an equivalent manager. This role supports manufacturing and engineering groups through inspection and review of raw and finished materials, and by reviewing manufacturing documentation to ensure high-quality production in a world-class manufacturing environment. Responsibilities include managing non-conformances, assisting with investigations, and overseeing equipment management. Adherence to QSR, ISO 13485, and Company's regulations is essential.
A Day in the Life of Our Sr. QC Technical Specialist
Draft or revise inspection and quality-related work instructions to ensure compliance with regulatory and internal requirements.
Review processes to ensure procedural compliance and recommend improvements within areas of responsibility.
Perform inspections across all QC areas (IQC, in-process, and final).
Conduct visual, dimensional, and functional inspections on components, subassemblies, and finished products as specified.
Apply recognized sampling plans to determine sample sizes.
Identify key inspection points and select appropriate tools/equipment for measurement.
Utilize functional test fixtures for components, subassemblies, and finished devices.
Document inspection results in compliance with GMP/GDP.
Review acceptance activities, including LHRs, DHRs, and SLHRs (sterilization records), for accuracy and compliance with Good Documentation Practices (GDP).
Document non-conformances and ensure timely investigation and resolution.
Manage equipment, including coordinating calibration and/or preventive maintenance per Equipment Specifications.
Support cleanroom environmental monitoring and quality control data reviews.
Assist engineering staff with process improvement projects to enhance quality inspection of products and components.
Communicate departmental and company needs to management.
Provide and coordinate training for new QC Technicians.
Perform other tasks as required to support the Company's Medical Quality System.
About You
Associate's degree in Mechanical, Industrial, Electrical Engineering or Technology, Life Sciences, or related fields is preferred.
Minimum of 10 years of experience in a medical device quality control role.
Strong written and oral communication skills; ability to read, write, and understand English.
Excellent interpersonal skills for interacting with other departments and team members.
Detail-oriented, computer literate, and professional demeanor; adaptable to changing environments and capable of working independently.
Ability to read and interpret engineering DWGs, product specifications, and procedures, and use metrology and other testing equipment.
Proficient in using inspection tools such as calipers, micrometers, vision systems (including optical comparators), coordinate measuring machines, and other measurement tools.
Ability to test components, in-process subassemblies, and finished products according to engineering DWGs, product specifications, and procedures.
Basic knowledge of MS Excel required; experience with MS Office, Google Suite, ePLM/eQMS systems, and MS Access preferred but not required.
Self-starter, team builder, and excellent communicator.