Quality Control Engineer

We are Precision Medical Technologies, a Contract Manufacturer of Orthopedic Implants and Instruments. We focus on progressive techniques, technology and innovation. Our team members are engaged, highly skilled and motivated. We are constantly striving to improve and better ourselves so that we can continue to grow as a team and as a business.

We offer tuition reimbursement, flexible scheduling, 401k match, competitive benefits, and a work environment where we encourage growth and learning. Our employee well-being is something we take seriously and offer different wellness programs and team events throughout the year. We partner with local the communities to offer help and support anyway we can and encourage our teams to get involved. At PreMedTec we not only make medical devices and instruments, we focus on creating a culture where everyone knows your name and can work together to get where we need to be.

POSITION SUMMARY:

The Quality Engineer works closely with the Quality Manager to ensure the company’s Quality System is implemented and maintained to comply with ISO requirements. Direct quality activities and resources to achieve company objectives for safety, quality, delivery, and cost. The Quality Engineer develops inspection strategies to ensure a quality product is being sent to the customer. The position ensures compliance with the organization's quality objectives as wells as, QMS, ISO, FDA, and other standards and regulations. Assist in Directing workers engaged in measuring and testing a product and tabulating data concerning materials, product, or process quality and reliability. Compiles and writes training material and conducts training sessions on quality control activities. This position may specialize in areas of quality engineering, such as incoming material, process control, product evaluation, product reliability, inventory control, and metrology.

DUTIES AND RESPONSIBILITIES (essential functions of the position):

•Input for internal manufacturing equipment/processes/systems (IQ/OQ/PQ) to ensure process capability and product/process quality.

•Determine appropriate tests, inspections, and validations to ensure components and products meet specification requirements.

•Root cause analysis, problem-solving, continuous improvement, and related corrective and preventive action as they relate to complaints, non-conforming material, and other quality data.

•Assist in the Development of test equipment and inspection systems (tooling, fixtures, gauging, instruments, equipment, software, etc), including appropriate calibration and preventive maintenance.

•Assist in ensuring gauging and test equipment is available for both internal and customer gauging.

•Disposition of nonconforming product.

•Input to, and development of, specifications, standards, test protocols, test reports, procedures, and other documentation and records related to the above-listed responsibilities

•Assist in quality reporting: tracking; compiling; and reporting quality metrics

•Review specifications to ensure appropriate specification, dimensioning, and tolerancing as they relate to inspectability.

•Perform Internal Audits of the Quality Management System

•Assist in Gage R&R projects.

•Coordinate with Manufacturing Engineering Manager, Operations Manager, and Materials Manager to develop and maintain a Quality Management System to ensure that parts are acceptable dimensionally and cosmetically at the machine, at finishing, at weld/assembly, and at laser marking while minimizing downstream inspection in Quality after these operations have been completed.

•Attend and/or lead Management Review meetings, present results of data analysis of Customer satisfaction, conformity of the product, trends of processes and/or products, and supplier evaluation results.

•Maintain written, measurable Quality objectives.

•Maintaining customer complaint files and establishing and maintaining procedures for receiving, reviewing, and evaluating complaints.

•Liaison with customer Quality personnel as required.

•Training and development for the Quality Department.

ESSENTIAL EDUCATION, SKILLS, EXPERIENCE, AND QUALIFICATIONS:

•5 years in related field experience

•Minimum of two years of college experience and/or 7 years of related field experience

•Capable of using statistical techniques: sampling theory, probability, reliability, capability, SPC, etc.

•Ability to read blueprints and interpreting GD&T

•Fundamental understanding of metrology, including common dimensional measuring instruments

•Excellent verbal and written communication skills

•Computer knowledge: MS Word; MS Excel, MS Project, etc

•Logical cognitive skills and ability to apply scientific methods

•Ability to identify variables affecting the quality

•Perform all duties of Corrective and Preventive Actions

NONESSENTIAL EDUCATION, SKILLS, EXPERIENCE, AND QUALIFICATIONS (not necessary but preferred):

•4-year college degree.

•Minimum of 3 years of quality assurance management experience in a manufacturing environment, preferably Medical.

•Ability to read and understand blueprints including GD&T and apply appropriate measurement techniques

•Effective problem-solving skills such as Lean Six Sigma, etc.

•Medical device or other health-related field experience

•ASQ Certified Quality Manager (CQM)

•CQM Certified Quality Manager

•Ability to perform FMEA / PFMEA

•Leadership / Supervision Experience

PHYSICAL DEMANDS AND WORK CONDITIONS:

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

•Must be able to work in a manufacturing environment.

•Eyesight and hearing must be correctable to a standard level.

•Regularly required to sit for extended periods; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 40 lbs.