Sr. Quality Control Technician- 1st Shift

The Senior Quality Control (QC) Technician performs inspection, testing, and documentation activities to ensure raw materials, components, and finished goods meet established quality

and specifications. The role conducts visual, dimensional, functional, and analytical testing in accordance with approved procedures and supports the identification and resolution of quality issues.

The Senior QC Technician is expected to work with a high degree of independence, demonstrate strong knowledge of quality systems and inspection practices, and provide technical guidance and support to other QC personnel.

• ◆Perform incoming inspection and testing of raw materials, components, and supplies against approved specifications, drawings, procedures, and acceptance criteria.
• ◆Perform final inspection and release testing of finished goods to verify compliance with established product and quality requirements.
• ◆Conduct visual, dimensional, functional, and analytical testing using approved methods and calibrated equipment.
• ◆Perform routine laboratory or analytical testing, which may include physical, chemical, or other product-specific test methods.
• ◆Accurately document inspection and test results in accordance with applicable procedures and Good Documentation Practices (GDP).
• ◆Review inspection and testing data for completeness, accuracy, and compliance with specifications.
• ◆Identify, document, and escalate nonconforming materials, products, or test results in accordance with established procedures.
• ◆Support investigations of nonconformances, deviations, out-of-specification results, complaints, and other quality issues as appropriate.
• ◆Assist with root-cause investigations and implementation of corrective and preventive actions (CAPA).
• ◆Ensure inspection and laboratory equipment is appropriately maintained, calibrated, and suitable for use.
• ◆Maintain QC records, samples, retain samples, and laboratory or inspection areas in accordance with applicable procedures.
• ◆Support material and finished-goods disposition activities by providing accurate and timely inspection and testing results.
• ◆Provide technical guidance and on-the-job training to QC Technicians and other personnel as needed.
• ◆Assist in developing, reviewing, and improving inspection procedures, test methods, work instructions, and related quality documentation.
• ◆Participate in continuous improvement activities focused on quality, efficiency, compliance, and reduction of defects.
• ◆Support internal and external audits and regulatory inspections as needed.
• ◆Collaborate with Manufacturing, Quality Assurance, Engineering, Supply Chain, and other functions to resolve quality-related issues.
• ◆Follow applicable safety, environmental, quality-system, and regulatory requirements.
• ◆Travel to our Framingham facility is required

• ✓High school diploma or equivalent required; associate degree or technical certification in a scientific, engineering, manufacturing, or quality-related discipline preferred.
• ✓Typically 1-2 + years of experience in Quality Control, inspection, laboratory testing, manufacturing, or a related technical environment.

• ✓Experience performing incoming, in-process, and/or finished-goods inspection.
• ✓Experience using inspection and measurement equipment such as calipers, micrometers, gauges, balances, or other applicable instrumentation.
• ✓Experience performing analytical or laboratory testing according to established methods and specifications.
• ✓Ability to read and interpret specifications, drawings, procedures, test methods, and other technical documentation.
• ✓Strong documentation skills and attention to detail.
• ✓Ability to identify quality issues, evaluate results against established acceptance criteria, and appropriately escalate concerns.
• ✓Basic computer skills and experience using electronic quality, laboratory, ERP, or manufacturing systems.
• ✓Experience working in a regulated manufacturing environment such as medical devices, diagnostics, pharmaceuticals, biotechnology, or other life-science industries.
• ✓Working knowledge of applicable quality-system

and Good Manufacturing Practices (GMP).

• ✓Experience with nonconformance investigations, CAPA, deviations, or out-of-specification investigations.
• ✓Experience with sampling plans and statistical inspection techniques.
• ✓Familiarity with laboratory instrumentation and analytical test methods relevant to the products or materials being evaluated.
• ✓Experience training or mentoring junior QC personnel.