Quality Control Technician III (2nd Shift)

JOB PURPOSE

QC Technician Ill is proficient performing inspections and testing at various stages of production of the product - from raw materials, sub-assemblies, and final assemblies to assure product quality and conformance to specifications and procedural requirements.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Interprets engineering drawings, schematic diagrams to complete incoming, in-process and final inspections.
• Able to use a wide assortment of QC inspection instruments to assure components and devices are manufactured and functioning according to specification.
• Analyzes problems, determines problem-solving techniques and exercises judgment in selecting appropriate solutions.
• Records test data and interpret its pass/fail status.
• Performs and documents all QA inspection and testing activities to assure conformance to specifications.
• Performs label inspections.
• Audits various manufacturing processes to assure compliance and product segregation.
• Maintains quality product in all stages of manufacturing and packaging process to determine proper sampling and variations in the process.
• Reviews donor records for compliance.
• Compiles and reviews device history records to assure compliance and releases products to Finished Goods.
• Initiates non-conformance reports (NCRs) and follows-up to final disposition of nonconforming materials.
• Assists in developing and implementing Corrective and Preventive Actions (CAPA's) using known problem-solving techniques.
• Assists in developing and implementing Document Change Orders (DCO's).
• Redlines/revises specifications as needed, to assure QSR compliance.
• Trains other QC Technicians on new or revised procedures.
• Investigates and reports complaints on existing products as directed by QA Management.
• Fills out and process quality reports and entering into the computerized quality reporting database.
• Performs and/or assists special projects as directed by Quality Team Lead, Manager or Director.

MINIMUM QUALIFICATIONS

• Education/Certifications: High School Diploma or equivalent required.
• Experience, Skills, Knowledge And/or Abilities: 7 years or more related experience.
• Knowledge of GMPs (QSR) and/or ISO 9001 and ISO 13485 regulations, Medical Device manufacturing experience, Cleanroom manufacturing experience.
• Experience with usage of common inspection tools (e.g., rulers, calipers): read blueprint drawings.
• Knowledge of computer software programs including Microsoft Word, & Excel.
• Experience with usage of inspection techniques and knowledge of statistical sampling plans.
• Strong attention to detail.
• Ability to balance and prioritize inspections and job responsibilities to support production.
• Focused with a strong sense of urgency.
• Good verbal and written communication skills, ability to communicate and interact well with all levels of personnel.
• Ability to work with a diverse group of people.

PREFERRED QUALIFICATIONS

• Education/Certifications: Technical College Associate’s Degree Bachelor’s Degree.
• Additional Experience, Skills, Knowledge And/or Abilities: ASQ Certifications such as but not limited to CQI or CQT.

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

• Frequent or continuous moderate lifting of 15-40lbs.
• Frequent or continuous pushing and/or pulling.
• Frequent or continuous standing.
• Frequent or continuous walking.
• Frequent or continuous repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers.
• Frequent or continuous bending, stooping, kneeling, or crouching.
• Frequent or continuous exposure to dust, fumes, gases, odors or other airborne irritants.
• Frequent or continuous exposure to chemicals and/or solvents.

COMPENSATION

The anticipated base hourly rate for an employee who is located in California this position is $26.36 to $33.00 per hour, plus bonus, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer and this pay scale may not reflect the pay scale for an employee who works in other states or locations.