Quality Engineer

Description

Must be onsite

Required Skills & Experience -:

• 2–3 years preferred; 5+ years considered overqualified –
• Background: Regulated industry (preferably medical devices) –
• Must-Haves: ISO 13485, CFR Part 820, CAPA and root cause analysis, IQ/OQ/PQ Education
• Requirement: Degree in Electric/Mechanical engineering (Candidates with Industrial/Chemical engineering degrees will be rejected)

Job Summary:

• 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 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).
• Attend functional and departmental meetings and follow up on action items accordingly.

Experience

• Minimum 2 years of professional experience, with a Bachelor´s degree
• Full clean driver’s license (desirable).