Quality Assurance Engineer Job in Parsippany 07054, New Jersey US
Job Summary Responsible for the planning and execution of all quality assurance aspects of the quality management system associated with the product realization of medical devices including design and production.
This position will interface extensively with other departments including vendors and suppliers to foster regulatory compliance and continuous improvement to meet and exceed customer expectations.
General Functions ¿Ensure quality related deliverables are met as defined by the product development process and project plans.
¿Provide quality engineering and assurance services and technical expertise to support product quality and overall system compliance.
¿Development of QC inspection techniques, testing methodologies, requirements, sampling methodologies, and inspection documentation (PIPs) to maintain the appropriate level of control and verification.
¿Manage the nonconformance and deviation system (MRB) for proper root cause investigations of product discrepancies as well as well-documented material dispositions.
¿Oversee, manage or support the corrective and preventive action system (CAPA) for both internal systems and external customers and suppliers.
Assist with root cause investigations to ensure that efforts lead to improvements and an effective quality system.
¿Trend analysis for common causes, scrap, and rework tendencies.
¿Development and review of internal operating procedures and specifications.
¿Evaluate product and process changes to assure compliance with regulatory, corporate and customer requirements.
¿Perform internal departmental and process audits to assess compliance to FDA, ISO and internal requirements.
¿Participation, creation and presentation of performance data for CAPA and management review system meetings.
¿Oversee and manage purchasing controls including purchase order reviews, vendor selection, and supplier qualification and approval.
¿Inspection gage design, fabrication, and calibration.
¿Support and understanding of principles and regulatory requirements for validation (process, software, methods, utility and equipment qualifications)¿Support and understanding of risk management and failure mode and effects analysis (FMEA) related to design and manufacturing.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.Expected Areas of Competence (ie KSAs) ¿Good understanding of procedures and concepts for quality assurance and quality engineering with respect to new product development, regulatory bodies, and inspection and process control.
¿Sound understanding of the requirements of the FDA medical device regulations (cGMP/QSR) and ISO 13485.
¿Familiarity with statistical analysis and sampling methodologies¿Familiarity with drafting standards and geometric dimension and tolerancing (GD&T).
¿Apply a broad range of quality engineering techniques to analyze, recommend, and implement process and product improvements in support of manufacturing, and system improvements.
¿Ability to effectively work within a team to expedite completion of critical project tasks with other functional groups.
¿Ability to work with minimal supervision and demonstrate ownership for integrity of work.
¿Work effectively with all departments including both salaried and hourly personnel.
¿Demonstrate good written, verbal, and presentation communication skills.
¿General knowledge of manufacturing processes, machinery, and technology specific to the development and manufacture of Trabecular Metal.
Education Requirements .¿B.S degree in biomedical, mechanical, industrial or other engineering science or equivalent amount of work experience in the quality field.
Skill Requirements Microsoft Office Suite and Project.
¿0-5 years experience desirable¿Knowledge of computer software such as Microsoft Office products, CAD, and database management.
¿GD&T and CMM programming abilities a plus¿Broad knowledge of medical device and orthopeadic industry a plusLicenses/Certifications ¿ASQ professional certifications such as CQE a plus¿Six Sigma a plusRequired Skills: CAPA experience, Supplier Quality, FMEA, Medical device or pharma experience, FDA StandardsJoin Aerotek CESM, one of the leading providers of engineering and engineering support professionals in North America.
Due to our growth, we’re constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across a number of different industries.
We know it’s more than just your day-to-day responsibilities that can make or break a job. It’s the support you get. That’s the reason Aerotek CE offers a variety of benefits including medical, dental, optical, 401k, and many more.
Don’t put your career in the hands of just anyone, put it in the hands of a specialist.
Join the Aerotek CE team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
Quality Assurance Engineer Job in Parsippany 07054, New Jersey US