Quality Control Inspector II

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION

The Quality Control Inspector II will be responsible for performing quality inspections and testing according to established procedures. Inspection and testing activities will cover incoming, work-in-process, and finished goods.  Selects random samples for tests at specified stages such as incoming or in production process, and tests products for variety of qualities, such as dimensions, performance, appearance, correct assembly, and other testing outputs.  Records test data, applying statistical quality control procedures.  Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with manager and functional experts on special department projects. Performs the essential duties and responsibilities listed in section below.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• Perform chemical assay of solutions as well as general laboratory maintenance.

• Performs in-process and final inspection of all products for conformance to specifications.

• Maintains and records quality testing information as part of a DHR (Device History Record).

• Maintains work areas and equipment in a clean and orderly condition.

• Must be able to work in a Team environment, multi-task and communicate effectively.

• Inspection and testing of raw materials, intermediates and recording of test results.

• Maintains a working inventory of all components and archived materials and solutions.

• Assist as needed in test method validation, implementation, and execution.

• Provide database support, generate reports and analyze process data.

• Assist in Out of Specification (OOS) and non-conformance (NC) investigations.

• Assist in preparing for and participating in FDA audits, customer audits, etc.

• Demonstrate excellent organizational and time management skills.

• Demonstrated competency of MS Suite.

• Perform other duties as required.

DESIRED MINIMUM QUALIFICATIONS

• Minimum required education and experience: High School Diploma or equivalent with 1+ years of experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated industry.

• Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.

• Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.

• Working knowledge of standard laboratory practices and safety.

• Ability to follow instructions precisely, recognize deviations, and recommend corrective action.

• Detail-oriented.

TOOLS AND EQUIPMENT USED

Calipers, rulers, dataloggers, standard office equipment (i.e. computers, phones, photocopiers, filing cabinets, other general office equipment).

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills required of position in order to successfully undertake the essential duties and responsibilities of this position.  In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak and have the ability to move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

ADVERSE WORKING CONDITIONS

The adverse working condit