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Job Requirements of Supplier Quality Engineer:
-
Employment Type:
Contractor
-
Location:
Marlborough, MA (Onsite)
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Supplier Quality Engineer
Careers Integrated Resources Inc
Marlborough, MA (Onsite)
Contractor
Job Title: Supplier Quality Engineer
Location Marlborough, MA 01752
Duration: 11 Months+ (Possibilities of Extension)
Shift & Timing: Regular Business Hour, Monday to Friday
Pay Range: Upto $55/Hour. on W2
Job Description:
- This position provides support to the Global Supplier Quality organization dedicated to the oversight of components, other materials & services. He/she will provide technical knowledge across the organization to ensure suppliers can meet all requirements.
Essential Duties and Responsibilities:
- Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier’s quality management.
- Conduct technical reviews of suppliers to understand their capability to make materials.
- Oversee, assess, and monitor suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection”.
- Define and approve PPAP (Production Part Approval Process) requirements for all new and revised purchased parts (as applicable). Follow up for their on-time completion.
- Work along with suppliers, to exceed the “fit, form and function” and reliability requirements, while working internally with Research & Development and Design Assurance.
- Issue and follow up on Agile Quality figures called “SCARs” and “SACAs” and “NCEs” related to suppliers. Monitor timing of the workflows to comply with key performance indicators established by Hologic.
- Work collaboratively with suppliers on problem solving and root cause analysis to avoid repeat failures. Apply (as applicable), metrology and statistical measurement to problem analysis and resolution.
- Work with Post Market Surveillance and other applicable departments (Quality Engineering, MFG Engineering, Research and Development, R&D, etc.) to address complaints linked to supplier situations.
- Resolve quality day-to-day issues associated with suppliers around the globe by addressing non-conformities: call into containment and work along with the corresponding departments to achieve disposition of the impacted material (return to supplier, rework, sort, etc.). As applicable, collect and send back samples to suppliers if needed.
- As a resolve of a PPAP certified part number, work with Incoming Quality to include suppliers in the “Skip Lot Program” (as applicable) or remove suppliers out of it if poor quality is detected.
- Maintain complete supplier quality records as per the applicable procedure (e.g., supplier performance key indicators, supplier’s quality certifications, etc.).
- Update suppliers’ files when required and check that the information is accurate and complete, assuring that all applicable regulatory standards are met.
- Support audits as a subject matter expert. Travel might be required, domestic and international.
- Update the ERP system with the status of the approved suppliers for the different materials (as applicable).
Qualifications/ Skills:
- Communication—must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.
- Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes.
- Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.
- High proficiency with Microsoft Office suite to produce reports, analyze data, etc. effectively.
- Ability to handle and manage multiple complex projects.
- Knowledge of project management techniques.
- Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001.
- Must be able to work independently and with all levels of the organization.
- ISO 13485 leader auditor (Desirable).
- Quality System Regulation.
- Risk management.
- Validations (IQ, OQ, PQ) and root cause analysis (CAPA process).
- PPAP (Desirable).
- Statistical Process Controls (SPC) and statistical sampling know how.
Experience:
- Minimum 2 years of professional experience, with a Bachelor s degree, in positions of a similar nature in the medical industry in the technical field, interacting with the quality management system.
- Full clean driver’s license (desirable).
- Proficiency written and oral in English. A second language is a plus.
Knowledge required (Desirable):
- Microsoft Office
- Internet
- Project, Visio, Mini Tab
- Agile: Yes (desirable)
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