Machine Operator Summary/Objective
The machine operator position operates extruders in the assembly process under supervision and direction of the manufacturing manager or designee.
Essential Functions
Perform typical extrusion, cutting, inspection, and packaging operations to support the manufacturing process.
Detects and reports defective materials or questionable conditions to the manufacturing manager or designee.
Maintains the work area and equipment in a clean orderly condition and follows prescribed safety regulations.
Performs prescribed preventative maintenance (P.M.) on machines as required per the P.M. charts.
Must be familiar with the basic machine functions to perform the tasks stated above.
Must be willing to accept and receive frequent supervision and assistance regarding machine set-up.
Follow standard work methods (Work Instructions).
Read routing and set up sheets and performs work assigned by the manufacturing manager or designee.
Must have technical capacity to understand processing complexities.
Required Education and Experience
High school diploma or GED.
Minimum of 1 year of factory-related experience.
Computer Skills
Able to read, write, and communicate in English to the degree necessary to perform the job.
Comfortable working within a manufacturing environment that includes machinery, moving parts, and noise
Ability and willingness to cross-train in other departments, learning to operate other machinery.
Preferred Education and Experience:
Experience as machine operator.
Training in general safety, electrostatic discharge awareness, foreign object damage awareness and quality system awareness.
Able to use calipers, micrometers, pin gages. MicroVu experience a plus
Basic knowledge of SPC
Ability to read/interpret prints/drawings
ERP experience a plus
Physical Demands
While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts and vibration. The employee is occasionally exposed to a variety of conditions. The noise level in the work environment and job sites can be loud, however AP provides PPE (Personnel Protective Equipment) to mitigate risk.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The Employee must frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Required to talk or listen, stand, walk, sitting, handle or feel using hands to finger, reach with hands or arms.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
This is a full-time position. Hours of work are Monday through Friday, 7:00 a.m. to 3:30 p.m., 40 hours per week.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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Quality Assurance Technician Summary/Objective
The Quality Assurance Technician is a detail-oriented professional who maintains an effective ISO9001documented quality system and can demonstrate compliance to the standard. This position reports to the Plant Manager, joins a dynamic team and is comfortable communicating with people throughout the organizations. QA Tech can solve problems, analyze data, works well with customers and vendors to resolve quality issues and is focused on continuous improvement. The Quality Assurance Technician is a natural coordinator who has a strong sense of big picture objectives and a sharp eye for detail
Essential Functions
Maintain DQS, quality records, and logs (e.g. NCMR, CAPA, and Internal/External Audit Records, critical Meeting Presentations, Rosters and Minutes, etc.), in compliance with ISO 9001/ ISO 13485 standards
Analyze data, develop and present Quality KPI’s and Metrics
Leading customers, vendors and internal MRB root cause investigations, risk assessments, deviations and change control
Provide TDS, SDS and regulatory information requested by customers
Ensure customer quality requirements are documented and met as part of contract review team
Process and product audits, support 3rd party audit activities, validate CAPA effectiveness
Ensure legal compliance with local, state and national regulations
Create procedures, work instructions and training materials
Training to inspection methods for incoming and outgoing product specs
Work with all departments when critical quality issues arise
Maintain the asset and calibration programs
Participate in and document QMS improvement projects and equipment qualifications
Implement testing plans
Competencies
Knowledge of the Quality System Regulation ISO 9001/ISO 13485 quality system standards with experience in inspections
Advanced knowledge of Microsoft Office programs (e.g. Word, Excel, and PowerPoint)
Experience with using an ERP system, JobBOSS2 preferred
Experience leading improvement projects
Excellent computer knowledge and data entry skills (Word, Excel, Outlook, etc.)
Strong analytical and problem-solving skills
Self-sufficiency and ability to work with minimal supervision
Strong and effective verbal and written communication skills
Attention to detail and discretion
Proven organizational skills, including time management
Ability to create a variety of instructions furnished in written, oral, diagram or schedule form
Ability to create documents such as safety rules, operating, cleaning and maintenance instructions and procedure manuals
Collaboration Skills. Demonstrate and promote teamwork on a consistent basis
Ability to work within a team environment and to accept supervision and guidance
Aptitude for math and ability to calculate production amounts, ratios, and percentages
Ability to generate and maintain organized and accurate records
Ability to organize tasks and judge priorities
Ability to communicate at multiple levels of an organization
Position Type and Expected Hours of Work
This is a full-time onsite position. Days and hours of work are Monday through Friday, 7:00 a.m. to 3:30 p.m.
Required Education and Experience
Quality management curriculum and/or equivalent combination of education and experience. Bachelor’s degree preferred
1-2 years’ work experience in a regulated industry, preferably medical devices
5 or more years of experience in an ISO 9001 or 13485 Quality Assurance role
QC/QA experience in a manufacturing setting
Skills/ Specialties include Process/ Quality Improvement
Working knowledge of MRP/ERP software
Ability to read and write English, follow verbal instructions, and use simple math
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
