Changing lives. Building Careers.

Joining us is a chance 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, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Staff Quality Engineer is a subject matter expert responsible for providing product quality and engineering leadership 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, leading cross-functional teams mentoring junior team members. Works with internal departments to ensure implementation, maintenance, and improvement of the quality management system.

Preferred professional certifications - CQE, CQA, CRE

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:

• The Staff Quality Engineer is an expert professional, working independently as subject matter expert with extensive knowledge of quality engineering. They lead moderate to significant improvements in processes, systems, or products and acts as a formal resource for colleagues with less experience

• 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

• Bachelor's degree, or higher, in Engineering, or Biological Sciences discipline with 10+ years of experience or equivalent education and years of experience.

• Min. 5-7 years' direct QE experience in a regulated med device, life sciences or pharma industry with direct experience in dFMEA and pFMEA.

• Min. 3-5 years' direct experience w/ ISO 13485, ISO 14971, FDA QSR, preferred experience w/ SPC (Statistical Process Control).

• On-site position in Boston, MA with transition to a brand-new state of the art facility in Braintree, MA in 2025.

• Versed in Design Controls.

• Probability & Statistics Working usage and knowledge of Probability & Statistics.

• Preferred professional certifications - CQE, CQA, CRE.

• Preferred Lean six sigma certification.

• Highly proficient in computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.

• Detail-oriented.

• Proficient with CAPA processes.

• Strong technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).

• Knowledge of statistical sampling and analysis.

• Working knowledge of medical device regulations (including FDA QSRs, ISO13485).

• Ability to communicate effectively (both written and oral).

• Must be able to observe company policies and safety procedures at all times.

• Demonstrated ability to work cross-functionally in a team environment.

• Quality Engineering/ Quality Compliance/ Quality Assurance experience in the Medical Device or similar FDA regulated industry.

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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