Integra LifeSciences Sr Engineer II, Quality CAPA Coordinator in Boston, Massachusetts
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The Sr. Engineer II, Quality is responsible for providing quality and engineering support to the Operations and Quality departments. Their primary objective is it lead the NC coordination process which will include action items within all QMS lifecycle activities. 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.
Reports to the Sr. Quality Manager.
May lead NC Owners within the NC Team.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
Lead in the identification and completion of CAPA activities, including CAPA investigations.
Coach NC owners and Review NC phases
Work with functional management to ensure NC are completed with quality an integrity in a timely manner
Support MRB meetings and CAPA management
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.
Reviews and approves validation protocols and reports for new and existing processes and equipment.
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.
Collects and reports quality metrics as required.
DESIRED MINIMUM QUALIFICATIONS
Bachelor degree or equivalent with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience.
Must have Bachelor degree or higher in Engineering, or Biological Sciences discipline.
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.
Certified Quality Engineer preferred, but not required.
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.
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position.
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to 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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