QC Technician II

Job Summary

The Quality Inspector is responsible for performing inspections of incoming materials, in-process products, finished goods, components, and new products to ensure compliance with quality standards and specifications. This role involves making accept/reject decisions, documenting inspection results, supporting quality initiatives, and maintaining compliance with cGMP, regulatory, and company procedures.

Key Responsibilities

• Perform incoming, in-process, and final product inspections by observing, measuring, testing, and recording inspection data.
• Compare inspection results against specifications and document any non-conformances.
• Make accept/reject decisions based on established procedures and quality standards.
• Perform in-process testing and identify out-of-specification (OOS) products.
• Ensure proper disposition of defective or non-conforming materials.
• Follow established sampling plans and Statistical Process Control (SPC) procedures.
• Maintain accurate inspection records and quality documentation.
• Provide technical support to Quality, Quality Engineering, and Product Support teams.
• Train new and existing employees on inspection procedures as needed.
• Review work performed by other inspectors when required.
• Support high-priority site projects and continuous improvement initiatives.
• Participate as a Subject Matter Expert (SME) during internal and external audits for incoming inspection processes.
• Collaborate with cross-functional teams including Manufacturing, Materials Management, Engineering, Facilities, EHS, and Product Support.
• Perform other quality-related duties as assigned.

Required Qualifications

• A High School Diploma or GED with 2+ years of relevant quality inspection experience; OR
• An Associate's Degree with 1+ year of relevant experience; OR
• A Bachelor's Degree or an equivalent combination of education and experience.

• Experience performing incoming inspection and/or in-process inspection in a regulated manufacturing environment.
• Knowledge of 21 CFR Part 820, cGMP, and ISO 9001 standards.
• Experience using Quality Management Systems such as SAP and Windchill.
• Familiarity with Statistical Process Control (SPC) and quality sampling techniques.

Preferred Qualifications

• Experience performing incoming inspection and/or in-process inspection in a regulated manufacturing environment.
• Knowledge of 21 CFR Part 820, cGMP, and ISO 9001 standards.
• Experience using Quality Management Systems such as SAP and Windchill.
• Familiarity with Statistical Process Control (SPC) and quality sampling techniques.

Required Skills

• Strong attention to detail and inspection accuracy.
• Ability to make sound quality decisions based on established procedures.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Ability to prioritize work in a fast-paced environment.
• Strong organizational and time management skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Proficiency with Microsoft Office (Word, Excel, Outlook).
• Commitment to workplace safety and quality.

Work Environment

• Protective equipment required, including gloves, safety eyewear, and lab coat.
• Exposure to biological materials, including blood products.
• Occasional gowning required.
• Weekend work and overtime may be required.

Physical Requirements

• Light physical demand level.
• Close visual acuity required.
• Occasional repetitive hand movements.
• Occasional lifting of 10-35 lbs.
• Occasional pushing, pulling, and use of a power jack.

Need Employee With Quality Incoming Inspection Or In-Process Inspection

We are seeking a Quality Inspector to perform inspections of incoming materials, in-process products, finished goods, components, and new products to ensure compliance with quality standards and specifications. This role involves making accept/reject decisions, documenting inspection results, supporting quality initiatives, and maintaining compliance with cGMP, regulatory, and company procedures.