Supplier Quality Engineer

Required Skills:1. Strong experience with component qualifications (PPAP preferred), Process Validation (IQ/OQ/PQ), and working with suppliers.2. Experience with remediating existing Quality Records to meet Good Documentation Practices (GDP) and rigorous attention to detail per FDA regulations.3. Experience working under aggressive project timelines that require collaborating with multiple functions including R&D, Manufacturing, QA and Incoming Inspection. Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation. Differentiating Factors: 1. Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. 2. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. 3. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. 4. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making. 5. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.