Associate Director Clinical QA Compliance ensuring quality and integrity of clinical development activities at BioNTech. Leading the proactive, risk - based Quality Strategy implementation across clinical trials.
About the role
- Principal Quality Engineer ensuring product quality and resolving quality concerns for Collins Aerospace. Acting as a liaison between customers and product teams, driving quality improvement and compliance.
Responsibilities
- Function as a liaison between the customer and Collins Aerospace to address quality concerns
- Represent the Quality function as member of the Integrated Product Teams (IPTs) to drive resolution of quality issues which may impact product performance and/or delivery results
- Lead investigations to determine compliance with quality management system standards, configuration assurance, contractual, customer, and business requirements
- Communicate improvement plans and progress to the organization and customers to improve both customer and internal metrics
- Drive resolution of conflicts and clarification in requirement flow-down; lead sites and teams using various improvement and root cause analysis methodologies
- Drive processes to develop, modify, apply, and maintain quality evaluation, control systems, and protocols
- Travel approximately 2x/quarter - Collins Aerospace locations, suppliers, or customers.
Requirements
- Typically requires a University Degree and minimum 8 years prior relevant experience or an Advanced Degree in a related field and minimum 5 years of experience
- Manufacturing experience
- Experience with the review of contractual requirements
- Engineering drawing requirements experience
- Experience with PPAP and APQP
- AS9100D or other Industry Standard experience
Benefits
- Medical, dental, and vision insurance
- Three weeks of vacation for newly hired employees
- Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option
- Tuition reimbursement program
- Student Loan Repayment Program
- Life insurance and disability coverage
- Optional coverages you can buy: pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection
- Birth, adoption, parental leave benefits
- Ovia Health, fertility, and family planning
- Adoption Assistance
- Autism Benefit
- Employee Assistance Plan, including up to 10 free counseling sessions
- Healthy You Incentives, wellness rewards program
- Doctor on Demand, virtual doctor visits
- Bright Horizons, child and elder care services
- Teladoc Medical Experts, second opinion program
- And more!
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