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Sr Quality Engineer.US-BOS.004

Posted on Jan 9, 2022 by Integra LifeSciences

Boston, MA
Research
Immediate Start
Annual Salary
Full-Time
Overview:

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.



 



Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.



But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.



 



At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.



 



Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.



 



Regardless of geographic location, our commitment is to offer the following, whenever possible:



Benefit plans that meet all local statutory requirements



A range of programs that reflect typical local market practices



An opportunity for employees to tailor benefits to their specific needs



Benefits that balance employee’s short-term and long-term needs



Click for more information regarding our benefits and total rewards program



Responsibilities:

Quality Engineering focuses on product compliance in support of Product Design and Manufacturing and including the critical quality system elements of CAPA and Complaint Investigations, Control of Nonconforming Product, Change Management, Risk Management, Process Validations/Test Method Validations, and Equipment Management. Works closely with Operations, Manufacturing Engineering, Design Engineering and Post-Market Surveillance groups to ensure a high level of product quality and effective and efficient corrective and preventive actions when needed.



 



To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily.  This position shall support Boston QA team by leading activities in the following areas as assigned:



CAPA investigations and action plan/VOE completion



Nonconforming Product investigations



Equipment Management activities



Support for Process Validations/Test Method Validations



Support for Changes to Design or Manufacturing



Risk Management activities



Complaint investigations



Collection and reporting of metrics and data as required.



QMS Remediation – workstream lead or team member



Site Improvement Initiatives



Development/Execution of Quality Plans



External Audit support



Daily operations activities for Site QA and/or Operations functions as assigned



 



NOTE:  Senior Quality Engineers are expected to serve as Subject Matter Experts and lead activities (e.g., lead CAPA investigator, remediation workstream leader). 



Qualifications:

BS degree in Engineering, Math or Science (Biology, Chemistry, Physics, Statistics, etc.) or 7-10 years of working experience in Quality Assurance/Control.



Minimum of 5 years’ experience in a regulated industry, preferably Medical Device Industry.



Certified Quality Engineer, preferred.



Working knowledge of QA Engineering related QMS elements including Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product).



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



Experience with CAPA processes (including central CAPA, Complaint Handling, Control of Nonconforming Product, OOT equipment analysis).



Working knowledge in investigational techniques.



Experience with Risk Management regulations and application (ISO14971).



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



Ability to communicate effectively (both written and oral) using English (or local language).



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



Ability to work independently with little supervision.



Proficient with the MS Office Suite. Some experience with Minitab and similar tools preferred.



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



In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.


Reference: 61311860

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