Sr. Supplier Quality Engineer

Job Title:
Sr. Supplier Quality Engineer
Number of Positions Available:
Job Description:
We are seeking a Sr. Supplier Quality Engineer with both superb abilities to identify and develop technical solutions as it relates to supplier quality with an innovative approach to a cost reduction plan for components managed by our Procurement Teams. You will support incoming inspection within our LivaNova Manufacturing Plant when they need escalation, your attention to detail and hyper-responsiveness is key to your success as an SQE. When it comes to ensuring that our suppliers respect our procedures, it will be up to you to build trusting and credible relationships. We expect you to utilize your in-depth knowledge as an SQE to ensure our supply chain partners continually develop their process in line with our designs, along with verifying their systems to ensure they are compliant. This will require your lead and collaboration with our on-going supply chain verification process. Overall, you will be responsible for delivering all aspects of the Supplier Quality Assurance function. We are looking for can-do attitudes; with a mindset of partnerships between our suppliers. We strive to implement best practices that emphasize defect prevention, reduction in variation and waste while providing for continuous improvements. You will be working collaboratively in the Pittsburgh plant along with counterparts in the US to collect root cause analysis, proving corrective feedback, preventing line stops due to supply issues. Our mission is to go above and beyond to achieve our specific requirements by offering technical support to suppliers, with the responsibility for ensuring that the products produced meet quality standards required to minimize quality costs and maximize customer satisfaction while ensuring that procedures and processes are met. Our culture is one of growth, learning, and moves at a very fast pace. Get the opportunity to lead with robust product builds following new product introductions to ensure continuity and improvement in supplier capability. Get beyond day one stuff, check out what year one and beyond will look like as an SQE: •Lead the supplier approval process by assessing manufacturing/technology capabilities and Health, Safety and Environmental Risks. •Support new product launches to ensure that supplier quality meets the required standards. •Carry out supplier validation audits, with supplier support and supplier advanced product quality planning (APQP or PPAP, SPQR: Supplier Process Qualification Review). •Work with the supplier directly, create corrective action plans to address process failures. •Supplier manufacturing processes - collaborate with suppliers on process improvement and value enhancement opportunities. •Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements. •Conduct benchmarking studies to determine best practices/designs and future trends.
Skill Requirements:
•Demonstrate the use of Quality tools/methodologies. •One or more ASQ Certifications a plus, such as CSQP, CQE, CQA, CBA, CMQ/OE, CRE. •Experience with Supplier and/or Internal Audits is a plus. •Direct experience in Manufacturing/Operations is a plus. •Experience with ISO 9001:2015 •Knowledge of FDA, cGMP, 21 CFR 820, ISO 13485:2016, and ISO 14971:2012 highly desired. •Advanced computer skills, including statistical/data analysis and report writing skills (Minitab/JMP/SAS experience is a plus). •Experience implementing various product and process improvement methodologies. •Ability to work in a highly matrixed and geographically diverse business environment. •Experience working with Engineering (Design, Quality, and Manufacturing Engineers) team to define process parameters and criteria to ensure supplier process capability is sufficient to meet product and process requirements.
Education Requirements:
You must possess at a minimum an accredited 4-year degree, Electromechanical Engineering preferred. Experience in new product development will be a must. You will need to have experience with developing a culture of cost management and must have a structured mindset for continued improvement. You will be traveling to suppliers and need to be autonomous in moving around the world, and able to integrate with the different cultures of our suppliers. Adaptability and understanding of different cultures will be critical in this role.
Company Description:
LivaNova is a global medical technology company built on decades of experience and a relentless commitment to improve the lives of patients around the world. As a worldwide leader in cardiovascular and neuromodulation solutions, we are dedicated to helping create meaningful products and therapies that transform lives each and every day. LivaNova is also dedicated to the highest standards, and we operate at the topmost level of business ethics and compliance.
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