Staff Quality Engineer

Summary The Staff Engineer, Quality is responsible for providing product quality and engineering support focused on product compliance in support of Product Design and Manufacturing, including the critical quality system elements, Complaint Investigations, Risk Management (pFMEA), Process/Test Method/Equipment Validations, Deviations, Control of Nonconforming Product, Product Holds, and Equipment management support to the Operations and Quality departments. Responsible for equipment and process improvement projects, supporting introduction of new processes or equipment into the facility. Leading investigational activities around non-conformances and CAPA’s. Works collaboratively with Operations, Manufacturing Engineering, Design Engineering and Post-Market Surveillance groups to ensure a high level of product quality and effective and efficient investigations when needed. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with manager and functional experts on special department projects. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system. Responsibilities Seasoned professional with complete and in-depth conceptual and practical knowledge in providing quality and engineering support decisions in a manufacturing environment. A self-starter that requires minimum supervision in the execution of primary responsibilities. Utilizes complete and in-depth conceptual and practical knowledge in own job discipline and basic knowledge of related job disciplines. Applies knowledge of job discipline's best practices to internal processes. Positions at this level are individual contributors that are also capable of leading cross-functional teams. Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development, and task force projects. Leads multi-disciplined team in the development and execution of Process FMEA and other applicable risk analysis as deemed appropriate. Oversees and participates in risk management processes, including the identification, evaluation, and mitigation of potential risks associated with product quality, safety, and regulatory compliance. Develop, collect, analyze, and report quality metrics. Develop statistically based sampling plans for in-process and final testing and inspections, and validations. Work with project teams to develop DOEs and statistically sound tests for appropriate support of results. Develop, review and approve validations and completion reports for new and existing products, processes and equipment. Provide statistical analysis of the data to support the reports. Ensure that all projects are compliant with GLP, QSR (including Design Controls), ISO or other applicable requirements. Formulate detailed product quality plans based on results of risk analysis. Support as required the quality management review process. Participate in FDA inspections, ISO certification and surveillance audits and customer audits. Support corporate regulatory affairs by providing information for submissions and annual reports. Identify and implement opportunities for continuous improvement. Audit internal groups or programs and external vendors for compliance with corporate and international regulatory guidelines. Interact and coordinate activities with other departments, external vendors and customers. Work with Product Development team in order to ensure all aspects of Design Transfer activities are being met. As required, assist or lead in the prompt implementation of non-conformance resolution. Identifying and investigating quality issues, conducting root cause analysis, and implementing corrective and preventive actions (CAPAs) to address non-conformities and improve product quality. Aid in the implementation SPC (Statistical Process Control) control systems with Manufacturing and Quality Control as applicable. Able to support manufacturing by analyzing process data and recommending changes to improve quality. Ability to follow instructions precisely, recognize deviations, and recommend corrective action. Provide training assistance, including providing training in quality system activities/requirements, and mentoring/coaching of junior peers. Perform other quality systems related duties as required. Perform other duties as required. Desired Minimum Qualifications A minimum of a Bachelor's degree in Engineering, Biological Sciences, or a closely related discipline with 8+ years’ of experience (or equivalent education and years of experience). Master's degree with 5+ years’ of experience (or equivalent education and years of experience). Doctoral degree with 3+ years’ of experience (or equivalent education and years of experience). Min. 5-7 years’ direct QE experience in a regulated medical device, life sciences, or pharma industry. Min. 5-7 years’ direct experience in dFMEA and pFMEA. Min. 3-5 years’ direct experience with ISO 13485, ISO 14971, FDA QSR. Preferred 3-5 years' experience with SPC (Statistical Process Control). Versed in Design Controls. Probability & Statistics: working usage and knowledge of probability & statistics. Preferred professional certifications – CQE, CQA, CRE. Salary and Benefits Salary Pay Range: $109,250.00 - $149,500.00 USD. The salary range is determined by role, level, and location and may be adjusted based on job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity, or other variable compensation. Pay transparency policies and benefits include medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insurance, and a 401(k) savings plan. Employees are eligible for total rewards based on their location and date of hire. EEO Statement Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans. Integra LifeSciences is committed to providing qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at View email address on click.appcast.io. #J-18808-Ljbffr TEI BIOSCIENCES INC