Sr Quality Engineer
Sr Quality Engineer
Posted on :
18-07-2025
Employer Active
1 Vacancy
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Job Description
Job Description:
- The Senior Quality Engineer is responsible to represent the quality engineering function to develop and execute the strategy to organize direct and report on all supplier quality-related activities for design and manufactured items made for the AST stapling business platform.
- Primary duties are focused on matter pertaining to supplier selection qualification manufacturing and review of technical quality documentation that includes Risk Management Documentation.
Responsibilities:
- Lead PPAP qualifications with the CMs.
- Collaborate with CMs to develop robust SCAPAs.
- Support the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
- Work with new and existing CMs/Suppliers to develop implement and maintain technical quality assurance systems and activities including MSAs SPC Quality Plans Control Plans and FMEAs.
- Collaborate on New Product Development (NPD) teams to evaluate and understand future CMs and their associated quality and development plans.
- Build and own the strategy for managing the CMs/Suppliers for the business.
- Communicate with the business Quality lead on CM initiatives updates and issues.
- Partner with Supplier Quality Managers to build a strategy for managing the CMs in all regions.
- Ensure CM compliance with business Quality Systems and all relevant internal procedures and policies.
- Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by CMs.
- Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by CMs.
- Develop communicate and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies etc.
- Ensure proper approval and documentation practices are followed for any process material or tooling change (SCR Supplier Change Request) at CMs.
- Define and manage the process for growing effective partnerships with preferred CMs (to drive optimal performance) founded on common interest and which demonstrate trust loyalty and financial success.
- Lead by Example: Setting continuous-improvement driven mentality and solid quality culture for the organization.
- Maintain compliance to set Key Performance Indicators for the business.
- Maintain the highest level of compliance and operational standards set by the business.
- Manage and report on CMs/Suppliers audit program in line with ISO and/or FDA 21 CFR part 820 regulations.
- Translate engineering manufacturing and quality requirements for CM products.
- Perform deviation investigations into quality issues arising from CM activities.
- Manage qualifications of changes and co-ordinates associated change control activities.
- Evaluate CMs using the appropriate CM performance management processes and develop reports on CM quality performance for company management recommend and implement the continuous improvement of CM quality systems.
- Responsible for ensuring that effective up-to-date CM Quality Assurance documentation procedures and specifications are maintained.
- Participate in annual supplier forums and business reviews.
Requirements:
- Bachelors Degree in an Engineering/Scientific/Electronic or technical field.
- Minimum 5 years experience in a Supplier Quality Quality Engineering or Reliability Engineering function.
- Activities PPAP.
- Design Failure Mode and Effect Analysis (DFMEA).
- Risk management documents.
- Supplier changes (PPAP) expertise.
- Risk management documents.
- Work with new and existing CMs/Suppliers to develop implement and maintain technical quality assurance systems and activities including MSAs SPC Quality Plans Control Plans and FMEAs.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
Key Skills
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