Manager, Quality Engineer
$68K - $88K/yr
Responsible for initiating and leading technical investigations, risk assessments (including FMEA ... Working conditions Must be willing to work weekends and evening hours as necessary. Must be willing ...
Manager, Quality Engineer
$68K - $88K/yr
Responsible for initiating and leading technical investigations, risk assessments (including FMEA ... Working conditions Must be willing to work weekends and evening hours as necessary. Must be willing ...
Manager, Quality Engineer
Miami, FL · On-site
$68K - $88K/yr
Responsible for initiating and leading technical investigations, risk assessments (including FMEA ... Working conditions Must be willing to work weekends and evening hours as necessary. Must be willing ...
Quick apply
Manager, Quality Engineer
Miami, FL · On-site
$68K - $88K/yr
Responsible for initiating and leading technical investigations, risk assessments (including FMEA ... Working conditions Must be willing to work weekends and evening hours as necessary. Must be willing ...
Manager, Quality Engineer
Miami, FL · On-site
$68K - $88K/yr
Responsible for initiating and leading technical investigations, risk assessments (including FMEA ... Working conditions Must be willing to work weekends and evening hours as necessary. Must be willing ...
Manager, Quality Engineer
Miami, FL · On-site
$68K - $88K/yr
Responsible for initiating and leading technical investigations, risk assessments (including FMEA ... Working conditions Must be willing to work weekends and evening hours as necessary. Must be willing ...
Identify high-risk processes and problems during launch pad and recovery system refurbishment and ... Available to work extended hours, nights, and weekends when required by mission milestones
Identify high-risk processes and problems during launch pad and recovery system refurbishment and ... Available to work extended hours, nights, and weekends when required by mission milestones
Cyro Design Engineer
Merritt Island, FL · On-site
... risk, information and configuration management; and schedule integration and analysis. Work ... Ability to work odd hours and various shits, including weekends as required, to support spacecraft ...
Cyro Design Engineer
Merritt Island, FL · On-site
... risk, information and configuration management; and schedule integration and analysis. Work ... Ability to work odd hours and various shits, including weekends as required, to support spacecraft ...
Author formal engineering rationales, risk assessments, and V&V testing protocols/reports that are ... Travel: 15% (out of town labs, surgeries, supplier visits) Occasional work on weekends ...
Author formal engineering rationales, risk assessments, and V&V testing protocols/reports that are ... Travel: 15% (out of town labs, surgeries, supplier visits) Occasional work on weekends ...
It will also focus on providing high-criticality and high-risk services, with the confidentiality ... Must be willing to work extended hours and/or weekends as needed. * This role requires you to be ...
It will also focus on providing high-criticality and high-risk services, with the confidentiality ... Must be willing to work extended hours and/or weekends as needed. * This role requires you to be ...
Security Engineer
Cape Canaveral, FL · On-site
It will also focus on providing high-criticality and high-risk services, with the confidentiality ... Must be willing to work extended hours and/or weekends as needed. * This role requires you to be ...
Security Engineer
Cape Canaveral, FL · On-site
It will also focus on providing high-criticality and high-risk services, with the confidentiality ... Must be willing to work extended hours and/or weekends as needed. * This role requires you to be ...
Security Engineer
Cape Canaveral, FL · On-site
It will also focus on providing high-criticality and high-risk services, with the confidentiality ... Must be willing to work extended hours and/or weekends as needed. * This role requires you to be ...
Security Engineer
Cape Canaveral, FL · On-site
It will also focus on providing high-criticality and high-risk services, with the confidentiality ... Must be willing to work extended hours and/or weekends as needed. * This role requires you to be ...
Cyro Design Engineer
Merritt Island, FL · On-site
$69K - $93K/yr
... cost, risk, information and configuration management; and schedule integration and analysis ... Ability to work odd hours and various shits, including weekends as required, to support spacecraft ...
Quick apply
Cyro Design Engineer
Merritt Island, FL · On-site
$69K - $93K/yr
... cost, risk, information and configuration management; and schedule integration and analysis ... Ability to work odd hours and various shits, including weekends as required, to support spacecraft ...
... engineering rationales, risk assessments, and V&V testing protocols/reports that are accurate ... work on weekends Qualifications Education and Experience: * Bachelor's degree in Mechanical ...
... engineering rationales, risk assessments, and V&V testing protocols/reports that are accurate ... work on weekends Qualifications Education and Experience: * Bachelor's degree in Mechanical ...
Occasional evening and weekend work may be required as job duties demand. Responsibilities * Design ... Contribute to risk management, configuration control, and change management processes Required ...
Occasional evening and weekend work may be required as job duties demand. Responsibilities * Design ... Contribute to risk management, configuration control, and change management processes Required ...
Identify high-risk processes and problems during launch pad and recovery system refurbishment and ... Available to work extended hours, nights, and weekends when required by mission milestones
Identify high-risk processes and problems during launch pad and recovery system refurbishment and ... Available to work extended hours, nights, and weekends when required by mission milestones
Senior Quality Engineer
Cape Canaveral, FL · On-site
$75K - $101K/yr
Ability to support occasional night shifts and weekend work and to travel as required by Test and ... make risk-based decisions, including determining when escalation is appropriate. Successful ...
Senior Quality Engineer
Cape Canaveral, FL · On-site
$75K - $101K/yr
Ability to support occasional night shifts and weekend work and to travel as required by Test and ... make risk-based decisions, including determining when escalation is appropriate. Successful ...
Identify high-risk processes and problems during launch pad and recovery system refurbishment and ... Available to work extended hours, nights, and weekends when required by mission milestones
Identify high-risk processes and problems during launch pad and recovery system refurbishment and ... Available to work extended hours, nights, and weekends when required by mission milestones
Execute enterprise supplier quality strategy through audits, assessments, risk reviews, and ... This may include work during evenings, weekends, and/or holidays. Additional work hours are ...
Execute enterprise supplier quality strategy through audits, assessments, risk reviews, and ... This may include work during evenings, weekends, and/or holidays. Additional work hours are ...
Systems Engineer II - Endpoint
Melbourne, FL · On-site
$113K - $120K/yr
... risk and exploitability, and track remediation to closure within defined SLAs. * Provide Tier 3 ... This role requires flexibility for after hours and weekend work, as needed, to perform changes and ...
Systems Engineer II - Endpoint
Melbourne, FL · On-site
$113K - $120K/yr
... risk and exploitability, and track remediation to closure within defined SLAs. * Provide Tier 3 ... This role requires flexibility for after hours and weekend work, as needed, to perform changes and ...
Ability to work weekends (as needed) for migration work. Soft skill - Leadership be a self-starter ... Can manage risk is a good decision maker. Understands the big picture can relate to the firms ...
Ability to work weekends (as needed) for migration work. Soft skill - Leadership be a self-starter ... Can manage risk is a good decision maker. Understands the big picture can relate to the firms ...
... weekend, and holiday on-call rotations. * This is a remote role that requires up to 40% travel ... Take primary support ownership for assigned systems or locations while escalating high-risk, highly ...
Quick apply
... weekend, and holiday on-call rotations. * This is a remote role that requires up to 40% travel ... Take primary support ownership for assigned systems or locations while escalating high-risk, highly ...
IT Operations Engineer
Cape Canaveral, FL · On-site
$58K - $79K/yr
Create and maintain auto-updating project management tools, schedules, performance metrics, risk ... Willingness to work extended hours or weekends as needed to meet critical deadlines. * Willingness ...
IT Operations Engineer
Cape Canaveral, FL · On-site
$58K - $79K/yr
Create and maintain auto-updating project management tools, schedules, performance metrics, risk ... Willingness to work extended hours or weekends as needed to meet critical deadlines. * Willingness ...
Weekend Risk Engineer information
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Manager, Quality Engineer
Miami, FL
VIVEX BIOLOGICS GROUP INC & SUBSIDIARIES
$68K - $88K/yr
Full-time
Posted 20 days ago
Key responsibilities
Manage Quality Assurance Engineers and Interns by assigning tasks, establishing schedules, and conducting performance reviews.
Review and approve process validation and equipment qualification protocols and reports.
Lead technical investigations, risk assessments, and process improvement initiatives using Lean principles.
Job description
Description
Job purpose
The Quality Engineer Manager will be responsible for developing, revising, and maintaining Quality processes, procedures, and metrics to support all functional areas at Vivex Biologics, Inc. This individual will be responsible for providing Quality guidance in process improvement and technology transfer efforts. The Quality Engineer Manager will oversee Quality Engineers and Interns in their day to day tasks as well as the timely completion of projects. This role will also be responsible for reviewing and approving process validation and equipment qualification (IQ, OQ, PQ protocols and reports. The Quality Engineer Manager is also expected to provide support to the Regulatory Affairs team by providing guidance with standards and regulations requirements for supplier qualifications, certifications and licensing, and audits.
Duties and responsibilities
- Manage Quality Assurance Engineers and Interns by managing schedules, assigning and prioritizing their workload, establishing due dates, and performing their performance reviews.
- Ensure company is in compliance with all internal policies and procedures and external federal, state, and governing body regulations and standards.
- Responsible for initiating and leading technical investigations, risk assessments (including FMEA, root cause analysis, and corrective and preventive actions related to non-conformances, deviations, and customer complaints.
- Work cross-functionally to provide quality and regulatory guidance to all functional areas in the organization.
- Participate in quality planning activities to evaluate existing and develop new measurement systems to evaluate and improve departmental output.
- Identify process improvement opportunities using Lean principles and lead the development and implementation of process improvements activities.
- Perform pre-validation assessments and review and approval of process validation and equipment qualification (IQ, OQ, PQ protocols and reports.
- Provide support to Regulatory Affairs in the completion of supplier qualifications and audits.
- Other duties as assigned.
Requirements
Qualifications
- A minimum of a Bachelor's degree in Engineering or a related technical discipline is required (e.g. Biology, Chemistry, etc..
- A minimum of 8 years of related Engineering or Quality experience is required.
- Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry preferred.
- Experience with Non-Conformances, Deviations, Complaints and Corrective and Preventive Actions (CAPAs) required.
- Experience with Process Validations and Equipment Qualifications.
- Expert knowledge in the interpretation and application of FDA, AATB, and ISO standards and guidelines.
- American Society for Quality (ASQ) certification preferred.
- Certified Tissue Bank Specialist (CTBS) certification preferred.
- Must demonstrate effective oral, written, communication and presentation skills.
Working conditions
Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled cleanroom manufacturing area where the engineer would be exposed to tissue processing.
Physical requirements
While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move objects weighing up to 30 pounds.
Direct reports
Quality Assurance Engineers and Interns