Job Information
Integra LifeSciences 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 Engineer II, Quality will be 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.
Primary responsibilities are to:
Intermediate level professional who understands and applies the principles and practices in providing quality and engineering support
Positions at this level are individual contributors and team members
Assist or lead customer complaint investigations and post-market surveillance activities.
Assist or lead in the identification and completion of CAPA activities, including CAPA investigations.
Assist or lead Nonconforming product activities, including investigations and coordination/management of MRB review and approval.
Supports design changes, process changes and new product development through team involvement and review and approval of documentation.
Develops and implements test method validations as assigned.
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.
pFMEA development and updates.
Supports risk management file updates.
Establishes statistically based sampling plans for inspections, verifications, validations, etc.
Establishes and maintains Quality Management System procedures related to areas of responsibilities.
Ensures compliance with cGMP, QSR, ISO 13485, MDD/EU MDR, and other applicable regulations and standards.
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.
Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.
Collect, Analyze and report Quality Metrics as required.
Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
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
Aid in the implementation SPC control system with Manufacturing and Quality Control.
Participates in internal and external audits.
Position is site based (on-site)
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Minimum required education and experience: Bachelor degree or equivalent with 3+ years of experience, Master degree with 0-2 years of experience
Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry)
A minimum of 0 – 3 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated product preferred environment.
Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.
Experience with CAPA and nonconforming product processes.
Experience with process/test method/equipment validations.
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.
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.
Certified Quality Engineer preferred, but not required.
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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