Quality Engineer (Medical Device, Life Sciences, or Pharmaceutical)
Less than 5 years experience • Medical Devices & Diagnostics
OVERVIEW OF POSITION:
This position is responsible for providing Quality Engineeringsupport on design projects and serving as a Quality Engineering resource to suppliers. This position is also responsible for investigating complaints and non-conforming material reports and initiating corrective and/or preventive actions when appropriate.
Main Job Duties/Responsibilities:
- Participates in design control projects providing quality engineeringsupport. Assists the design control project team with the development of essential design control deliverables including, but not limited to: complaint analysis on similar products, risk analysis, failure mode and effects analysis (FMEA), essential requirements checklist, and design verification / validation.
- Develops inspection techniques that include identification of characteristics, sampling plans, and gauging. Recommends gauging techniques including gauge work instructions – assures gauges provide repeatable and reproducible results through the use of statistical techniques.
- Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerancing, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques. Recommends revisions to assure design requirements are specified in the appropriate detail to provide a successful design transfer. * Participate in product transfers to assure design activities are complete and appropriate transfer plans with specific quality criteria are established.
- Serves as Quality Engineering resource for suppliers. Assists suppliers with the interpretation of quality requirements. Works with suppliers to resolve conflicts and recommends revisions as required.
- Uses quality tools to implement improvements including: process flowcharting, pareto analysis, correlation and regression analysis, significance tests, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.
- Performs supplier audits and participates in the qualification of new suppliers. Evaluate supplier quality data and initiate action when data analysis supports the need for improvement.
- Assists with the development of protocols to ensure processes and products are validated with the appropriate level of confidence.
- Investigate and analyze internal failures and customer complaints. Perform trend analysis and generate reports. Recommend and implement corrective and preventive measures as necessary.
- Review non-conforming reports and recommend/approve disposition of products. Initiate action where indicated to prevent recurrence of non-conformities.
- Review and approve Engineering Change Control Requests/Orders for Quality function.
- Maintain current knowledge to ensure compliance to applicable quality/regulatory standards/requirements (e.g., FDA QSR, ISO13485, MDD).
- Participate in cross-functional teams as a representative of Quality Engineering.
- Handle quality related requests/questions from internal and external sources.
- Perform job duties in a manner consistent with company's core values.
- Perform other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
- Bachelor’s Degree in Mechanical Engineering or related Engineering field.
- Quality Engineeringexperience in a medical device manufacturing environment preferred. CQE, CQA, CRE a plus.
- Must demonstrate knowledge of quality problem-solving tools, such as FMEA and SPC.
- Must demonstrate knowledge of federal/international regulations and Quality System Standards (e.g., FDA QSR, ISO13485) and their application to the QMS.
OTHER SKILLS and ABILITIES:
- Strong attention to detail and accuracy.
- Self-starter – demonstrates initiative.
- Excellent interpersonal skills – ability to work well with others.
- Excellent communication skills – both verbal and written.
- Excellent organization skills – plans work, executes plan and maintains organized work area.
- Proficient PC application skills to include Windows, Microsoft Word, Excel. Mini Tab and Solidworks (CAD) a plus.
- Flexible - ability to adapt to changing requirements and priorities.
- Responsive problem solver and action-oriented.
- Presents a professional image.
- Ability to function well under pressure and expend effort to meet schedules and deadlines.
- Willingness and ability to assume increased responsibility.
The physical demands described here 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. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include normal vision.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet to moderate
Job Type: Full-time
- Medical Device: 2years
- Pharmaceutical Industry: 2years
- Project Teams: 1year
- Life Sciences Industry: 2years