Integra LifeSciences Sr. Engineer II Quality in Boston, Massachusetts
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
The Sr. Engineer II, Quality is responsible for providing quality and engineering support to the Operations and Quality departments. Designs equipment and floor layouts. 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 Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
• Seasoned professional with complete and in-depth conceptual and practical knowledge in providing quality and engineering support decisions.
• 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,
• 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
• Bachelor's degree or equivalent with 8+ years of experience, Master's degree with 5+ years of experience, Doctoral degree with 3+ years of experience, including or in addition:
• Must have Bachelor's degree or higher in Engineering, or Biological Sciences discipline
• Min. 3 – 5 direct QE experience in a regulated med device, life sciences or pharma industry.
• Min. 3 - 5 years direct experience in dFMEA and pFMEA.
• Min. 3 – 5 years direct experience w/ ISO 13485, ISO 14971, FDA QSR
• Preferred 1 – 3 years' experience w/ SPC (Statistical Process Control)
• Preferred 1 – 3 years' experience w/ MSA (Measurement Systems Analysis)
• Versed in Design Controls
• Probability & Statistics Working usage and knowledge of Probability & Statistics
• Preferred professional certifications – CQE, CQA, CRE
• Highly proficient in computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
• Able to support manufacturing by analyzing process data and recommending changes to improve quality.
• Ability to query databases and generate reports.
• Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
TOOLS AND EQUIPMENT USED
Ability to utilize a computer, telephone, smart phone as well as other general office equipment. Strong computer skills are required.
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
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.
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