All Of Our Groups
Healthcare
QualityAssuranceRepresentative–Commissioning,Qualification&Commercialization(CQCQ)
“Quality Assurance Representative – Commissioning, Qualification & Commercialization (CQC-Q) at All Of Our Groups. Skills: Quality Assurance, Medical device manufacturing, Contract manufacturer oversight. Provide QA oversight for manufacturing process design. Ensure risks to product quality are identified”
Industry & Context.
Problem-solving; Root cause analysis
5–25% travel, Domestic travel, International travel
What They're Looking For.
Must Have
Bachelor's degree in technical/scientific discipline, 5–7+ years relevant industry experience, Knowledge of Quality Systems, Knowledge of validation/qualification, Knowledge of manufacturing processes, Working knowledge of global regulations, Experience with contract manufacturers, Experience with suppliers, Ability to influence cross-functional teams, Ability to influence external partners, Written communication skills, Verbal communication skills, Basic knowledge of statistics, Basic knowledge of risk management, Ability to investigate quality issues, Ability to analyze quality issues, Ability to drive resolution of quality issues
Nice to Have
Attention to detail, Problem-solving skills, Decision-making skills, Audit experience with medical devices, Audit experience with GMP, Experience with Kneat, Experience with Agile, Experience with TrackWise, Experience with Microsoft Office tools, Technical writing capabilities, Ability to explain validation concepts, Ability to explain quality concepts, Experience leading manufacturing readiness assessments, Experience driving improvements, Organizational skills, Time management skills, Self-management skills, Ability to mentor peers, Contribute to continuous improvement
What You'll Do.
Provide QA oversight for manufacturing process design
Ensure risks to product quality are identified
Ensure risks to product quality are mitigated
Ensure risks to product quality are validated
Lead technical transfer
Support technical transfer
Lead commercialization of medical devices
Support commercialization of medical devices
Assess contract manufacturer QMS
Approve contract manufacturer QMS
Participate in design reviews
Participate in development reviews
Ensure manufacturability
Support process validation
Support qualification activities
Conduct manufacturing readiness assessments
Identify quality gaps
Drive remediation of quality gaps
Participate in pFMEA reviews
Participate in internal audits
Participate in regulatory compliance activities
Work support continuous improvement
Establish Quality Agreements
Maintain Quality Agreements
Provide QA consulting
Act as escalation point
Coach junior QA team members
Mentor junior QA team members
Influence best practices
How You'll Work.
Team & Collaboration
Cross-functional teams; External partners
Communication Scope
Written communication; Verbal communication
Process & Methodology
Change management
Applying for this Quality Assurance Representative – Commissioning, Qualification & Commercialization (CQC-Q) role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about All Of Our Groups?
Real rants from real employees. Read before you apply.