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Staff Supplier Quality Engineer

  • LocationSomerset, NJ 08873 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:3 days ago
  • Job no: 39997
  • Category: Quality

Job Description

Our client, a leading medical device company, is currently seeking an accomplished Staff Supplier Quality Engineer to join the team. Here is an overview of the role:

1) Provide technical guidance and quality subject matter expertise for all process development activities

2) Maintain a high level of knowledge related to current domestic and global regulatory trends

3) Identify and lead quality process improvements driving higher levels of performance in process development quality support systems

4) Participate in industry forums and regulatory compliance panels to represent company and provide input to proposed changes to standards and practices

5) Act as a consultant for manufacturing risk assessments and, as appropriate, process FMEA updates

6) Provide quality subject matter expertise and guidance related to Quality Management Systems processes and tools

7) Review and approve quality documentation as delegated from quality management

8) Monitor quality process metrics related to new development processes and coordinate activities to meet the performance goals for process transfer

9) Coach and mentor quality associates for quality processes providing support for technical issues, as appropriate

10) Support regulatory and customer audits as a quality process SME and acts as front room host to auditors

11) Lead meetings with Manufacturing Quality Engineers to share process issues, resolution and opportunities for improvement during development

12) Develop metrics for quality data and reporting to functional leaders monthly and quarterly for management review

13) Recommend/lead improvements in methods and procedures to improve overall quality within development processes and systems

14) Provide review and input to quality staff associates to facilitate issue resolution solutions balancing company and compliance requirements

15) Support a continuous improvement culture utilizing six sigma and lean techniques to improve products and processes

16) Provide supplemental review and approval for ECNs and validation protocols as delegated by quality management

17) Lead improvements for compliance in all areas to medical device regulatory requirements

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the medical device industry is strongly preferred

4) Preference will be given to candidates with recent experience in quality engineering

This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience

  • Published on 14 Jan 2022, 11:44 AM