Apply on Employer Site

Applied Medical Technology, Inc. (AMT) · 1 day ago

Quality Engineer

Brecksville, OH

Full-time

Onsite

Mid Level

3+ years exp

Applied Medical Technology, Inc. (AMT) has been in the enteral device product development and manufacturing business since 1985, based near Cleveland, Ohio. They are seeking a Quality Engineer to develop, implement, and maintain quality improvement activities, support the CAPA program, and address customer complaints.

Health CareManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Product 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

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

Qualification

ISO 13485FDA QSRQuality System SOPsStatistical analysisMechanical test equipmentElectrical test equipmentMS OfficeCommunication skillsProblem-solvingTeamwork

Required

Four Year degree, preferably in a technical discipline

3-5 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

Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures and/or governmental regulations

Ability to write reports, business correspondence and/or procedure manuals

Ability to effectively present information and respond to questions from groups of managers, clients, customers, vendors, non-engineers and/or the general public

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

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

Maintains a valid Driver's License

Knowledge of modern business communication, office procedures and methods

Skill to use a personal computer and various software packages such as Microsoft Office Suite

Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork

Benefits

AMT offers major medical, dental, and vision insurance at the first of the month following 30 days of service.

AMT offers several other voluntary benefits including hospital indemnity, critical illness, term life insurance & long term disability (company paid), among others.

AMT matches 100% of your contribution, up to 3% of your salary.

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

Annual Employee Appreciation Picnic

Tuition Reimbursement

Employee Referral Bonus Program

Employee Assistance Program

Company

Applied Medical Technology, Inc. (AMT)

Applied Medical Technology, Inc.

Founded in 1986

Brecksville, Ohio, USA

501-1000 employees

http://www.appliedmedical.net

H1B Sponsorship

Applied Medical Technology, Inc. (AMT) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (1)