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Career Opportunities: Sr. Engineer, Supplier Quality (Audit) - Merrimack, NH (25413)

  • Getinge Group
  • Merrimack, NH 03054
  • Full-Time

Job Function Summary: Ensure the performance of all required supplier maintenance activities meet current quality needs and to improve supplier performance and productivity.Strategically plan, develop, promote, and implement programs designed to improve supplier performance and productivity and reduce overall costs.Plans, organizes, and reports supplier performance to provide key information to the department manager and outside departments .Participate in supplier selection process and perform supplier audits to evaluate supplier capabilities, quality systems, processes and services.Perform validations and qualification of supplier to qualify manufacturing process and overall quality of part/component manufacturing.Assists incoming quality and participates in MRB process to resolve internal and external quality audit findings related to purchased products.Own and relentlessly drive supplier root cause analysis and corrective actions to prevent re-occurrence of quality issues.Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements.Ensure primary suppliers have adequate control plans, schedules, and resources to make continued improvements to incoming quality of supplied products .Works with Engineering and Quality to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing and assist in the development of inspection methods and improve sampling plans for new materials and components.Identifies non-conformance trends; develops and administers technical investigations and corrective action programs to resolve recurring quality problems.Provide technical assistance to suppliers/other resources performing qualification/validation testing.Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvementsCreate and maintain a plan to help with the development of direct reports and their professional growth.Assist lead auditor with performing audits. Assist in special projects as needed.Contributes to team effort by accomplishing related duties as requested.Required Knowledge, Skills and Abilities:Good verbal and written communication skills.ISO 13485 or 9001 Audit experience required, certification is a plus.High level of attention to detail.knowledgeable in the areas of lot acceptance, sampling methodologies, MSA/GR&R, CAPA, root cause analysis, and other statistical techniques.Working knowledge to applicable regulations and standards such as FDA, QSR, ISO, and MDD preferred.CQA, CQE, Six Sigma certifications would be a plus.Minimum Requirements:Bachelor's Degree in Engineering or Science field5 to 8 years' experience in a QMS environment with 2 to 4 years working as a supplier quality engineer;.Working knowledge of GMP, FDA, and ISO standards is desirable .Proficiency in MS Office applications (Word/Excel/PowerPoint/etc.) is required .Strong verbal and written communication skills (English).Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.#LI-DV1

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