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Airclean Systems is Hiring a Quality Engineer Near Brecksville, OH
DescriptionSince 1985, our core business has been enteral device product development, design, manufacturing, and engineering in a state-of-the-art facility near Cleveland, Ohio. AMT’s steady growth consistently creates job opportunities in Northeast Ohio. We are always searching for new talent and would love for you to join our team! We strive to keep the small company feeling while still reaching users all over the globe.
Position SummaryDevelop, implement, maintain and support activities for quality improvement and manufacturing programs. Support the CAPA program and address customer complaints.
Duties And ResponsibilitiesThis list is not comprehensive but meant to represent the most common or important duties of the position. Other duties will be required and/or assigned.
RequirementsMinimum Qualifications:
Mathematical Skills: Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Certificates, Licenses, Registrations: Maintains a valid Driver’s License.
Essential Job Functions: Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons.
Equipment Used: Telephones, computer, other office equipment as needed, electrical and general hand tools.
Special/ Additional Requirements: Persons in this position may be required to pass a drug, alcohol, and/or criminal background check.
AMT is Equal Opportunity/Affirmative Action Employer.
Benefits
Position SummaryDevelop, implement, maintain and support activities for quality improvement and manufacturing programs. Support the CAPA program and address customer complaints.
Duties And ResponsibilitiesThis list is not comprehensive but meant to represent the most common or important duties of the position. Other duties will be required and/or assigned.
- Creation and modification of labels
- Creation and modification of directions for use
- Product/packaging testing and evaluation
- Maintain employee training
- Annual sterilization testing
- Lead product quality investigations to a successful conclusion
- Execute risk assessments, collect supporting information and provide recommendations for management consideration
- Interface with other departments to provide guidance on CAPA completion
- Provide technical guidance to QA and QC personnel
- Represent quality interests and concerns on project teams
- Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements
- Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection
- Creation and maintaining of QA work instructions and related production quality procedures
- Collect, analyze, trend and communicate quality data throughout the organization
- Identify and help facilitate continuous improvement, corrective and preventive
- Resource in Engineering Change Order review process
- Mentoring, education and training of QA personnel
- Assume additional responsibilities as necessary at the discretion of QA
- Develop programs and methodologies for analyzing and presenting quality system data
- Identify program opportunities for improvement and drive procedure updates when required
- Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements
RequirementsMinimum Qualifications:
- Four Year degree, preferably in a technical discipline
- 1-5 years related experience in a regulated environment, preferably medical device
- Proficiency with MS Office
- Familiarity with use of mechanical and electrical test equipment
- Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing
- Ability to analyze and aggregate data using statistics
- Experience preferred with ISO 13485, ISO 14971 and FDA QSR for Medical Devices
Mathematical Skills: Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Certificates, Licenses, Registrations: Maintains a valid Driver’s License.
Essential Job Functions: Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons.
- Mental: Must be able to effectively communicate with others; complete and understand complex analysis of numbers; read, analyze and interpret written materials; meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems.
- Physical: Must be able to hear and verbally communicate for hours at a time, use computer equipment, electrical and general hand tools. Moderate noise level and limited exposure to physical risk.
Equipment Used: Telephones, computer, other office equipment as needed, electrical and general hand tools.
Special/ Additional Requirements: Persons in this position may be required to pass a drug, alcohol, and/or criminal background check.
AMT is Equal Opportunity/Affirmative Action Employer.
Benefits
- Insurance: AMT offers major medical, dental, and vision insurance at the first of the month following 30 days of service.
- Other Benefits: AMT offers several other voluntary benefits including hospital indemnity, critical illness, term life insurance & long term disability (company paid), among others.
- 401k: AMT matches 100% of your contribution, up to 3% of your salary.
- Paid Time Off (PTO): In addition to nine paid holidays, AMT provides employees with paid time off (determined by length of service), starting on day one
- Family-oriented, Positive Working Environment
- Discretionary Yearly Raises
- On-site Vending & Gym
- Company Happy Hours & Annual Employee Appreciation Picnic
- Tuition Reimbursement
- Employee Referral Bonus Program
- Employee Assistance Program
Job Summary
JOB TYPE
Full Time
SALARY
$92k-111k (estimate)
POST DATE
05/28/2024
EXPIRATION DATE
06/20/2024
WEBSITE
aircleansystems.com
HEADQUARTERS
Creedmoor, NC
SIZE
100 - 200
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The job skills required for Quality Engineer include Product Quality, Communicates Effectively, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer. Select any job title you are interested in and start to search job requirements.
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The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.
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