ATR International
We are seeking a Sr Quality Engineer for a very important client
Careers that Change Lives A Day in the Life The Senior Quality Engineer position on the team supports new product development for Surgical Instruments In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team An understanding of mechanical and electro-mechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED: • Actively participate in product development cycle by reviewing mechanical/electro-mechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements. • Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart, complaint analysis, etc. • Collect, analyze and interpret statistical data Performs analyses and provide reports to management as required. • Contributes to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities, as required. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses. • Assisting with projects and assuring proper and consistent implementation of the quality engineering tools. • Provide solutions to a wide range of difficult challenges Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. Embedded Responsibilities: • Excellent organizational and communication (oral and written) skills Ability to work on teams as well as individually Able to set and meet goals Organized and detail oriented Problem solving and analysis skills.
Requirement:
BASIC QUALIFICATIONS: MUST HAVE: MINIMUM REQUIREMENTS: EDUCATION REQUIRED: • B.S degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality • Preferred: M.S degree in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality
YEARS OF EXPERIENCE: • Nice to Have: 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline)
SPECIALIZED SKILLS OR EXPERIENCE: • Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external. • Experience in a regulated industry • Experience with Minitab or similar statistical analysis tools • Experience with Risk Management Tools • Good interpersonal skills Ability to work effectively in a team environment and build strong working relationships • Ability to work in a fast-paced environment Ability to work well under pressure and maintain positive, enthusiastic attitude • Strong attention to detail and accuracy Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills). • High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning
NICE TO HAVE • ASQ Certified Quality Engineering (CQE) • Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements • Understanding of software and hardware interface
Top 3 technical skills that are required for the role: 1.Risk Management (Hazard Analysis, DFMEA, UFMEA) 2.Design Verification Authoring and Execution 3.General NPD QE skillset. (Change control, CAPA, Iso 13485 understanding)
Education Required: Bachelors of Engineering
Years' Experience Required: 4
PHYSICAL JOB REQUIREMENTS The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
DISCLAIMER The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Benefits:
Benefits Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.
Compensation Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.
Work Authorization ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.
ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.
Careers that Change Lives A Day in the Life The Senior Quality Engineer position on the team supports new product development for Surgical Instruments In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team An understanding of mechanical and electro-mechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE ASSIGNED: • Actively participate in product development cycle by reviewing mechanical/electro-mechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements. • Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart, complaint analysis, etc. • Collect, analyze and interpret statistical data Performs analyses and provide reports to management as required. • Contributes to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities, as required. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses. • Assisting with projects and assuring proper and consistent implementation of the quality engineering tools. • Provide solutions to a wide range of difficult challenges Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives. Embedded Responsibilities: • Excellent organizational and communication (oral and written) skills Ability to work on teams as well as individually Able to set and meet goals Organized and detail oriented Problem solving and analysis skills.
Requirement:
BASIC QUALIFICATIONS: MUST HAVE: MINIMUM REQUIREMENTS: EDUCATION REQUIRED: • B.S degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality • Preferred: M.S degree in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality
YEARS OF EXPERIENCE: • Nice to Have: 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline)
SPECIALIZED SKILLS OR EXPERIENCE: • Fundamental understanding of electro-mechanical designs and manufacturing processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external. • Experience in a regulated industry • Experience with Minitab or similar statistical analysis tools • Experience with Risk Management Tools • Good interpersonal skills Ability to work effectively in a team environment and build strong working relationships • Ability to work in a fast-paced environment Ability to work well under pressure and maintain positive, enthusiastic attitude • Strong attention to detail and accuracy Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills). • High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning
NICE TO HAVE • ASQ Certified Quality Engineering (CQE) • Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements • Understanding of software and hardware interface
Top 3 technical skills that are required for the role: 1.Risk Management (Hazard Analysis, DFMEA, UFMEA) 2.Design Verification Authoring and Execution 3.General NPD QE skillset. (Change control, CAPA, Iso 13485 understanding)
Education Required: Bachelors of Engineering
Years' Experience Required: 4
PHYSICAL JOB REQUIREMENTS The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
DISCLAIMER The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Benefits:
Benefits Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.
Compensation Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.
Work Authorization ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.
ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.