Talntly is seeking a Quality Engineer for a manufacturing client of ours located in Harrison, Ohio. The position will be onsite Monday-Friday, 6-2:30 pm or 7-4 pm. The ideal candidate will have manufacturing and production experience and be confident in their ability to become a Quality Manager.

*Job Responsibilities:*

* Implement applicable Quality Management systems plans and procedures to ensure compliance to internal ISO requirements
* Assist in the implementation of ISO 13485:2016 medical devices into the medical quality system
* Expand receiving and inspection process
* Lead and assist in root cause analysis and facilitate the corrective/preventative action of Quality issues
* Perform data analysis and provide charts and reports to promote continuous improvement and create a proactive team environment through coaching and motivational techniques.
* Participate in NPD using risk analysis tools to eliminate design, manufacturing, and customer issues from occurring.
* Review non-conforming material, and disposition, implement corrective and preventative actions, and communicate with suppliers and the Quality Manager regarding action and improvement.
* Maintain and communicate information on customer returns including warranty analysis and dispositions.
* Administer and update Quality information system activities for CARs, calibration, and document control.
* Provide training to Quality Technicians, Team Leads, and Operators regarding established quality processes.
* Travel to customers to review product quality issues, troubleshoot, and implement fixes.

*Job Requirements:*

* Bachelor’s degree in an Engineering discipline is required
* 4-8 years of experience in a Manufacturing Environment working with quality/process improvement.
* Medical equipment experience is desired
* Excellent written and verbal communication skills and the ability to work well with people.
* Must have strong organizational, analytical, and problem-solving skills.
* Experience with ISO 9001:2015/13485:2016 and other related business standards.
* Experience with 8D methodology, Control Plans, and PFMEA desired.
* Ability to effectively handle multiple projects simultaneously.
* Ability to work with minimal supervision and possess a willingness to make autonomous decisions.
* Six Sigma Lean GB certification is desired.
* Willingness to travel up to 10 - 15%

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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Job Type: Full-time

Pay: $75,000.00 - $95,000.00 per year

Schedule:
* 8 hour shift
* Monday to Friday

Ability to commute/relocate:
* Harrison, OH: Reliably commute or planning to relocate before starting work (Required)

Experience:
* Quality assurance: 2 years (Preferred)

Work Location: One location