Quality Engineering Manager - Wheeling
4 weeks ago
Job summary
We're a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership and teamwork. Our associates take pride and ownership in their work innovating to provide the highest quality life-enhancing medical technology in the world.The Quality Engineer is responsible for overseeing all aspects of quality systems process at an FDA ISO regulated environment This highly responsible role requires strong leadership skills managing a team of 20+ associates including direct reports
- Support Viant Values: Customer Oriented Integrity Servant Leadership Own It Teamwork Be Agile.
- Provide strategic leadership for quality assurance regulatory programs ensuring continuous improvement compliance with FDA ISO requirements.
- Lead design implementation maintenance systems document control training corrective preventive action discrepancy handling complaint handling product release environmental monitoring review approve quality system documentation develop maintain procedures QA regulatory functions collaborate plant leadership corporate quality drive adherence processes achieve KPIs manage indirect inspection teams improve efficiency resolve root causes interact customers suppliers ensure relationships satisfaction handle direct selection training development personnel coach mentor team members oversee internal external audits CAPA programs implement corrective actions improve product qualify communicate revisions validations acts on revisions validations audits customer requirements interpret implement corrective actions address product issues requested customers maintain robust QMS meets FDA ISO customer requirements perform other duties as needed Requirements Bachelor degree Engineering Quality related field experience years Quality Assurance Regulatory Affairs medical device manufacturing regulated industry Automotive Aerospace experience precision machining metal processing Must Strong knowledge ISO FDA Corrective Action Plans processes experience internal external audits maintaining robust QMS Knowledge CMM programming inspection systems ability read interpret blueprints technical drawings proficiency MS365 applications Word Excel PowerPoint Experience Oracle IQS Required Experience Power BI user level Preferred Experience Minitab statistical analysis Physical Requirements Performs light non-strenuous administrative activities regular basis Occasionally lifts up to lbs carries up to lbs may involve minimal bending pushing/pulling crawling climbing balancing standing extended periods Maintains manual dexterity handle manipulate small items effectively Requires visual acuity distinguish colors assess spatial relationships focus fine details e.g using microscopes similar equipment Travel Minimal overnight travel by land air Benefits Medical dental vision benefits-effective date hire Company-paid life insurance disability benefits Generous Paid time off Holidays paid Company Match Tuition Reimbursement Voluntary Universal Life Long-Term Care Voluntary Legal Plan Pet Insurance Home Ownership Program We offer market competitive compensation Potential salary range role $120k-$140k Actual pay will determined based on experience qualifications geographic location job-related factors permitted law #INDMP Viant global medical device design manufacturing services provider partners innovates customers provide highest qulaity life-enhancing devices through depth breadth capabilities end-to-end integration technical expertise relentless focus customers operational excellence With nearly associates locations worldwide we offer unique combination small-company service big-company resources For more information visit or follow us LinkedIn Viant provides equal employment opportunities EEO employees applicants employment regard race color religion gender sexual orientation national origin age disability marital status amnesty covered veteran accordance applicable federal state local laws complies state local laws governing nondiscrimination employment location facilities
Job description
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