Cytophil, Inc Hiring for Medical Device Quality Associate Job at East Troy, WI Full Time

Medical Device Quality Associate: Responsible for performing activities for quality assurance/control of manufacturing, and packaging medical devices, and with direction given from Management. This is a first or second shift, full time position.

Principal Responsibilities:

• Perform quality assurance/control operations under SOP’s (Standard Operating Procedures) for medical devices in ISO clean room environment
• Document all phases of assembly per SOP’s (Standard Operating Procedures) to maintain FDA, ISO, regulatory, and GMP compliance.
• Work with continuous improvements; feedback, review, and execute revisions on processes and SOP’s
• Perform quality assurance/control operations of packaging and shipping activities, and assist with receiving processes
• Perform manufacturing verifications, line clearance, label, device history record, and material handling

Additional Quality Related Responsibilities

• Issuance of manufacturing lot numbers, and generating associated paperwork
• Assist with product testing; specifically, in-coming, in-process and release testing
• Perform and/or coordinate equipment calibrations, cleanroom, and environmental monitoring
• Provide support to the quality management system through:
• § Active tracking and documentation (e.g., control charts)
• § Assist in nonconformances, CAPA investigations, validations, and qualifications; with opportunity to move to project management

Required Skills:

• Ability to use Microsoft Word and Excel, and other basic computer functions
• Basic math skills (addition, subtraction, multiplication, and division)
• Must have exceptional documentation. Attention to detail a must.
• Good organizational, problem solving, and analytical skills
• Ability to work independently and as part of a team
• Proactively questions when appropriate for direction and decision process.

Work Environment:

• Work is performed in Lab, ISO Clean Room, and assembly/packaging areas.
• Light to medium lifting is required (up to 45 lbs).

Educational Requirements

• An associate degree or two years of higher education in scientific/technical field or biology/chemistry, or one to two years experience in the chemical/food manufacturing field, quality control, and/or quality management system experience in a regulated facility or equivalent.
• Preferred: Medical device manufacturing experience or Bachelor’s degree in scientific/technical field or biology/chemistry. Three or more years experience in the chemical/food manufacturing field, quality control, and/or quality management system experience in a regulated facility or equivalent.

Job Type: Full-time

Pay: $17.00 – $30.00 per hour

Benefits:

• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Holidays
• Monday to Friday
• Overtime

Ability to commute/relocate:

• East Troy, WI 53120: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• Manufacturing: 1 year (Preferred)

Work Location: One location