Quality Engineer III-Mitek, Raynham, MA Job in Raynham, Massachusetts US
DePuy Mitek is currently recruiting for a Quality Engineer 3 in Raynham, Mass.
DePuy, Inc., develops and markets products under the DePuy Orthopaedics, Inc., DePuy Spine, Inc., Codman Shurtleff, Inc., and DePuy Mitek divisions. DePuy Orthopaedics, Inc., provides products for reconstructing damaged or diseased joints, and for repairing and reconstructing traumatic skeletal injuries; DePuy Spine, Inc., develops, manufactures and markets innovative solutions for a wide range of spinal pathologies and recently introduced CHARIT, the first artificial spinal disc. Codman Shurtleff, Inc., provides products for the surgical treatment of neurological and central nervous system disorders through products such as hydrocephalic shunt valve systems, implantable drug pumps and micro-surgical instrumentation. DePuy Mitek offers innovative devices in sports medicine for the treatment of soft tissue injuries.
Job Description:
Supporting the New Product Development Quality Group for the Access and Advanced Energy Platform, the qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multi-discipline team, must be self-motivated, and have excellent written and verbal communication skills.
Working in a design team setting, this individual's major responsibilities will be as follows (but not limited to): NPD team member focused on life cycle management activities related to the DePuy Mitek AE Platform. Enhance the Mitek Design Control and Risk Management processes to better reflect Electromechanical, Capital and Software driven equipment and devices. Apply statistical methods to evaluate test data and processes. Perform Gage RR studies. Collaborate with the WW Service Team to review, trend and track AE capital equipment data from our WW Service Centers and feed information back into the Mitek NPI process for continuous improvement. Support transfer to manufacturing activities for AE products - NPD and base business. Conduct and lead process validation activities. Conduct and lead design / process failure mode effects and analysis. Develop inspection methodology and acceptance criteria for inspection sample plans. Conduct internal audits of the quality system to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements. Conduct audits of new suppliers as part of the project teams. Provides leadership in all areas of the Quality System, including, but not limited to Corrective Preventive Actions, Complaints, Post Market Surveillance Nonconforming Materials, Risk Management, etc. Provides leadership in the understanding of medical device regulations to other disciplines. This candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as RD, Regulatory, Manufacturing, and Marketing.
Qualifications
A minimum BS degree in an engineering or technical discipline with a minimum of 3-5 years of related experience in related field is required. A Master's degree is a plus.
Proficiency with the Microsoft Office Suite is required.
Strong working knowledge of electromechanical standards and requirements such as IEC, UL, Human Factors and Reliability Engineering to ensure integration into the NPI process and product designs is strongly preferred.
Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is strongly preferred.
Blueprint literacy including GDT preferred.
Knowledge of the QSR and ISO quality requirements is preferred.
Previous experience in a medical device or a healthcare discipline is strongly preferred.
Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations. This candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals.
This position will require up to 10% domestic / international travel. This position will be based in Raynham, MA and does not offer relocation benefits.
If you want to explore the many small-company environments behind the big-company impact of the Johnson Johnson Family of Companies, bid on this position today!