Quality Control Inspector at APOLLO RENAL THERAPEUTICS LLC – Ocala, Florida

Division/Department: Quality Assurance

Reports to: Quality Assurance Manager

ESSENTIAL DUTIES AND RESPONSIBILITIES

To ensure that the products made by Artemis meet our quality guidelines and satisfy the customers’ specifications and expectations throughout all stages of manufacturing.

Primary Functions

Responsible for:

• Reading and understanding design drawings; analyzing and interpreting blueprints, work instructions, data, manuals, and other materials to determine specifications, inspection and testing procedures, adjustment and certification methods, formulas, and required measuring instruments.
• Inspecting incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials.
• Approving First Piece Inspection which shall verify that the set-up parameters in the injection molding process are proper and producing acceptable parts. This inspection will be performed based on the Product Specifications for that product.
• Performing product inspection by following the Product Specifications and recommended techniques for that particular product. Inspection consists of rounds to each machine and box/bag audits.
• Verifying, during product audits, that product is packaged and weighed properly.
• Verifying that containers are properly labeled and bulk products are put into proper bins.
• Stamping approved boxes/bags of product with inspection stamp, verifying that boxes/bags are properly sealed, and verifying appropriate boxes are properly stacked on skids, if required.
• Ensuring that once a mold is pulled from a machine, indicating the completion of a production run, that the First and Last shots are retained and stored properly.
• Assisting the Quality Manager in data collection, GR&R studies, calibration of inspection equipment, etc.
• Recording observations on the Record of Inspection form, routing all pertinent information required per the Product Specification sheet, and recording any information or problems that should be passed on to the next shift’s Inspector.
• Reporting all out of specification, non-conformances appropriately.
• Providing feedback to supervisor regarding safety, fit, tolerance, quality, appearance or questionable procedures and practices.
• Maintaining safe and healthy work environment by following standards and procedures, complying with legal regulations. Familiar with federal regulatory agencies and international quality standards.
• Arriving at work in a timely manner to receive daily job assignment and be at workstation prior to the start of shift

Secondary Functions

• Recommends improvements in productivity and organization within respective departments.
• Segregates and documents defects as they are discovered during inspection.
• Advises Quality Assurance Manager on findings that pertain to quality.
• Assists others in lifting and moving of heavy objects (e.g., moving boxes of parts during or after inspection).
• Updates job knowledge by participating in educational opportunities, reading technical publications, etc.
• Follows regulatory requirements as they pertain to assigned job responsibilities.
• Works well with others.
• Performs other duties as required.

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

Education and/or Work Experience Requirements

• High School diploma or equivalent.
• 3+ years of inspection experience with various measurement tools (such as, vision system, calipers, gauge pins, and microscope). 2+ years performing medical device inspection (With a higher degree of specificity and regulatory rigger).
• Experience reading and understanding design drawings.
• Experience using quality measurement tools such as pin gauges, microscopes, etc.
• Strong vision, and good eye-hand coordination to effectively use various measuring instruments.
• Must be detail oriented, and able to work with minimum supervision.
• Must be able to work cooperatively in a team environment.
• Knowledge of computer software (MS suite, measuring systems), and spreadsheet software required.

Preferred Requirements

• Specialized training: ASQ Certification CQI or CQT desirable, but not required
• Prefer experience with vision measurement systems, including programming (e.g., Keyence or MicroVu).
• Some college courses or certificates in Quality Assurance field of study.
• 2+ years’ experience performing medical device inspection and using a Quality Management System database.

Competencies

• Judgment: Makes sound decisions; bases decisions on fact rather than emotion; analyzes problems skillfully; uses logic to reach solutions.
• Knowledge and use of computers and various software (Microsoft Word and Excel, measurement system), and ability to input and understand data. This will require long periods of sitting and manipulation of computer equipment, such as a mouse and keyboard. Improper posture can lead to fatigue and other problems.
• Cooperation/ Teamwork: Works collaboratively and effectively with others to get a job done; responds positively to instructions and procedures; shares critical information with everyone involved in a project; helps to set a tone of cooperation within the work group and across groups; acts and communicates respectfully; when appropriate facilitates discussion before decision-making process is complete.
• Commitment to Quality of Work: Maintains high standards despite pressing deadlines; does work right the first time; corrects own errors; regularly produces accurate, thorough, professional work.
• Commitment to Safety: Understands, encourages, and complies with safety policies and procedures; completes all required Environment, Safety and Health (ES&H) training; takes personal responsibility for safety.
• Job Knowledge/ Technical Knowledge: Demonstrates knowledge of techniques, skills, equipment, procedures and materials. Applies knowledge to identify and resolve issues and internal problems; works to develop additional technical knowledge and skills.
• Problem Solving: Anticipates problems; sees how a problem and possible solutions might affect other departments; gathers information before making decisions; weighs alternatives against objectives and arrives at reasonable decisions; adapts well to changing priorities, deadlines and directions; works to eliminate processes which do not add value; is willing to take action and take informed risks; recognizes and accurately evaluates problems; analyzes current procedures for possible improvements; notifies supervisor of problems in a timely manner.
• Attention to Detail: Follows detailed procedures and ensures accuracy in documentation and data; carefully monitors gauges, instruments, or processes; concentrates on routine and non-routine work details; organizes and maintains a system of records.
• Reliability: Personally responsible; completes work in a timely, consistent manner; works hours necessary to complete assigned work; regularly present and punctual; arrives prepared for work; committed to doing the best job possible; maintains a “can do” attitude; and keeps commitments.
• Proven ability to maintain focus and work effectively with multiple demands.
• Team player with strong interpersonal skills
• Must be able to demonstrate learning agility and critical thinking skills

Expertise and Personality

• Excellent time management and organizational skills
• Strong communication skills both verbally and written

PHYSICAL DEMANDS AND WORK ENVIRONMENT

Physical Requirements

• Able to effectively communicate both in written and verbal form in English.
• Execution of duties may include repetitive lifting, reaching, standing, squatting, kneeling, pushing, pulling, bending, and hand usage. These activities will require that one be in general good health.
• Strong vision (use of glasses and/or contact lenses are fine, if needed), and good eye-hand coordination to effectively use various measuring instruments. Good eye & hand coordination to see and use various measuring instruments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with company policy.
• Must be able to talk, listen and speak clearly face-to-face, in meetings, and when required on the telephone.
• Must be able to lift and carry up to 35lbs.