Its fun to work in a company where people truly BELIEVE in what theyre doing!
Were committed to bringing passion and customer focus to the business.
Join a high-impact quality team where youll drive the QMS activities that keep our Dallas site audit-ready compliant and performing at its this role youll champion continuous improvement elevate regulatory maturity and ensure our QMS processes not only meetbut exceedregulatory customer and medical-device requirements. Youll help prepare the site for regulatory and registrar audits support certification readiness and partner with functional leaders to strengthen processes that reduce COPQ improve yield and enhance overall product quality.
As the business process owner for CAPA and Internal Audits youll lead critical quality initiatives while collaborating across manufacturing engineering logistics sales and Global Quality. This role is perfect for a quality systems professional who thrives on cross-functional teamwork training others managing projects and making a measurable impact. If youre ready to elevate quality performance and help ensure exceptional outcomes for our customers this is your opportunity.
- Support site teams in continuous improvement and maturity focusing on assigned Business Process Owner (BPO) areas.
- Provide coaching and mentoring to ensure success in execution and audit readiness.
- Write effective CAPA responses to regulatory findings and lead improvements in QMS infrastructure for ISOrequirements.
- Facilitate training sessions for audit preparedness and ISO certification support.
- Manage and improve quality metrics including inspection reduction defect elimination rework reduction and yieldimprovements.
- Collaborate with cross-functional teams to develop capabilities address challenges and drive strategic initiatives.
- Communicate technical information clearly to senior management customers and teams influencing decisions and aligninggoals.
- Lead without direct reports fostering collaboration team building and professional growth through mentorship.
- Manage multiple projects ensuring timely and accurate delivery while meeting firm deadlines.
- Demonstrate business acumen with negotiating skills the ability to handle difficult conversations and fiscal responsibility inbudget planning.
- Exhibit high energy organization and attention to detail driving alignment with organizational objectives and industry bestpractices.
- Work autonomously escalating issues as needed and balancing operational needs with financial constraints.
- Ability to travel occasionally (2-3 times per year) domestically and internationally.
- Other duties and responsibilities as assigned.
QUALIFICATIONS:
- A bachelors or higher degree or 6-8 years experience in any combination of Quality Systems and regulatory affairs required.
- Familiarity in FDA Device Good Manufacturing Practices (GMP) is preferred.
- Expertise in ISOAS9100 and 14001 standards.
- Proven experience in leading projects performing quality audits and authoring procedures.
- Proficiency in quality data analysis tools and investigation methods.
- Preferred certifications: Six Sigma (Green/Black Belt) American Society of Quality (ASQ) CMQ/OE CQA RAPS ProjectManagement or Lead Auditor.
- Experience in Medical Aerospace/Defense or Automotive industries required.
- Background in large or mid-sized electronics manufacturing preferred.
Skills Required:
- Proficient in use of Lean and Six Sigma or other process improvement methodologies and quality tools (i.e. Pareto ChartHistogram SPC Flowchart etc.).
- Proficient in use of PFMEA Control Plans Measurement System Analysis APQP and PPAP.
- Proficiency in interpretation of assembly prints and drawings.
- Excellent English communications skills (verbal and written)
- Able to effectively present information to top management public group and/or customers.
If you like wild growth and working with happy enthusiastic over-achievers youll enjoy your career with us!
Creation Technologies is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex gender identity sexual orientation race color religion national origin disability protected Veteran status age or any other characteristic protected by law.
If you require any accommodations to complete the application process or need the job posting in an alternative format please email You will be connected with our Talent Acquisition team.
If you are contacted regarding the position please inform our Talent Acquisition team of any accommodations you may need during the recruiting process. All information related to accommodation requests will be handled confidentially.
Canada: Title for the position will be in accordance with applicable national and local laws.