Design Assurance, Quality Engineer (Medical Device Manufacturing)

SRG, the leader in the Life Sciences human capital industry, is looking for a Design Assurance, Quality Engineer as a potential candidate to join our clients Medical Device quality team onsite in the greater Boston area. This role focuses on identifying and implementing improvements in production and process controls. This is a contract position.

*Please be advised that we are in the process of considering potential candidates in preparation for this anticipated role.

Key Responsibilities:

• Assist in product and process design activities, including process development, validation, test method creation and validation, fixture design and qualification, and ensuring necessary updates to design history files are properly executed.
• Maintain and update risk management plans, hazard and risk analyses, failure mode and effects analyses, and risk management reports to evaluate product risks.
• Work with operations quality engineers to ensure design controls and maintain PFMEA to DFMEA & EDO linkages. Review production lines to ensure proper implementation of process controls.
• Develop and validate test methods. Apply metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices. Conduct measurement system error studies like Gage R&R.
• Utilize quality tools and statistical techniques to determine sample sizes, collect and summarize data, identify data distributions, analyze relationships between variables, design and analyze experiments, calculate reliability, assess process and performance capability, draw confident conclusions, and make statistically supported decisions.
• Conduct root cause analysis of identified issues and determine appropriate corrective and preventive actions. Use NC and CAPA systems as needed to structure activities.

Qualifications:

• Bachelor's degree in a technical discipline, such as engineering or science (equivalent experience may be considered).
• Quality engineering or design assurance experience in the medical device industry (2-5 years)
• ASQ certification preferred (e.g. CQE, CQA, CMDA, CRE, CSSGB/CSSBB).
• Basic understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820.
• Proficient in MS Office, and Minitab or other statistical softwares.
• TRAVEL REQUIRED: 10% - 20% (some international travel required)

* Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.