· Performs inspections using standardized methods

· Performs incoming, in-process and final inspection of components, documents, service parts and finished devices

· Collects/Gathers inspection results data into tracking systems

· Performs quality data analysis and presents key performance metrics to leadership monthly and quarterly

· Maintains calibration system and perform calibration duties, such as:

· Calibrating manufacturing and QA/QC equipment per schedule

· Coordinating with outside vendors for external calibrations and repairs

· Reviewing all calibration documentation for completeness and accuracy

· Maintains all quality records (Training, Drawings, Procedures, Work Instructions and Device History Records)

· Maintains plant training matrix, coordinating plant training on all quality topics

· Maintenance of audit checklists and production records to ensure they record verification of critical to quality attributes

· Leads weekly MRB meetings for nonconforming material

· Assists in investigations of customer complaints to determine root cause and completes investigation work-flow

· Strict compliance to Quality Systems standards.

· Complies with Good Documentation Practices.

· Adheres to all safety policies and contributes to the achievement of safety goals & objectives.

· Provides ideas and actively participates in the implementation of written suggestions for continuous improvement.

· Effectively utilizes time, energy and resources to meet delivery goals.

· Maintains housekeeping standards in accordance with 5 S principles.

· Complete all required training applicable to assigned position.

· Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.

Required Skills

Required Experience

· High School graduate or equivalent.

· 2 – 3 years of previous experience in a quality related function within a manufacturing environment.

· Ability to calculate mathematical equations such as arithmetic, fractions, algebra, statistics, and geometry.

· Ability to define problems, collect data, establish facts, and draw valid conclusions. Demonstrated understanding of problem-solving techniques.

· Ability to read and understand blue prints, bill of material, drawings, specifications, and instructions.

· Ability to use basic measuring equipment.

· Strong computer skills with demonstrated computer competency with Microsoft Office Suite, ability to run reports, and analyze data.

· Demonstrated ability to work in a team environment.

· Demonstrated ability to work with minimal supervision.

· Effective verbal and written communication skills.

· Must have thorough understanding of Current Good Manufacturing Practice (CGMP) and ISO 13485.

Must have physical ability and manual dexterity necessary to perform the duties pertaining to job.

REQUIRED SKILLS

• Familiarity with routine operating procedures of equipment which can be set up and operated following a few step by step instructions and the skill to operate the equipment. 
• Skill to perform minor clerical tasks incidental to the operation of the equipment (e.g., maintain machine operating and maintenance records, write new identification labels for computer tapes, etc.)
• Skill to perform routine maintenance such as cleaning and lubricating the equipment
• Ability to identify if improper machine operation and make basic adjustments
• In depth knowledge of the mechanics and capabilities of insert machine
• Mechanical aptitude
• Ability to understand written instructions, set-up the press, and carry out instructions
• Verify job ticket specifications, including any special work instructions before beginning the job
• Keep work area staged with product
• Perform quality control during each mailing to ensure product meets USPS requirements
• Check final inserts for proper folding, sealing, address placement, sequencing and delivery
• Communication skills both written and verbal
• Ability to be flexible on hours during certain times of the year as well as work overtime, weekends and holiday
• Maintain a clean area

OTJ-MAN