Quality Engineer Position Available In Bristol, Massachusetts

job summary: A Quality Engineer is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery in the Mansfield, MA area. This Senior Quality Engineer responsible for driving process improvements, managing risk, resolving nonconformances, and ensuring compliance with ISO/FDA standards in a manufacturing environment.

location:

Mansfield, Massachusetts job type: Contract salary: $54.98 – 76.81 per hour work hours: 8am to 5pm education: Bachelors responsibilities: Support continuous improvement initiatives in product and process characterization.

Manage Non-Conformance (NC) reports: initiation, investigation, analysis, review, and closure.

Collaborate with third-party suppliers to resolve NC issues.

Conduct internal and supplier audits in compliance with ISO 13485 and 21 CFR 820.Develop and implement process control and monitoring methods based on risk assessment.

Collect and analyze statistical data to support process improvements and operational decisions.

Lead investigations and documentation of nonconformances, CAPAs, and customer complaints.

Ensure escalation of critical quality issues when appropriate.

Own and enforce material identification, segregation, and defect classification processes in manufacturing.

Evaluate the effectiveness of preventive and corrective actions.

Review and guide root cause investigations per established methodologies.

Skills:

Prior experience in manufacturing or operations is required.strong knowledge of FDA and ISO risk management practices.

Proven experience in risk mitigation and corrective action implementation.

Certified Internal Auditor for ISO 13485.Advanced knowledge in quality engineering principles and statistical methods.

Education and Experience:

Bachelor’s degree + 8 years experience,Master’s + 5 years, orDoctorate + 3 years. #LI-AG1 qualifications: Experience level:

ExperiencedEducation:

Bachelors skills:

QualityComplianceManufacturing Equal Opportunity Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. job detailssummary$54.98 – $76.81 per hourcontractbachelor degreecategorycomputer and mathematical occupationsreference1094681job details job summary: A Quality Engineer is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery in the Mansfield, MA area. This Senior Quality Engineer responsible for driving process improvements, managing risk, resolving nonconformances, and ensuring compliance with ISO/FDA standards in a manufacturing environment.

location:

Mansfield, Massachusetts job type: Contract salary: $54.98 – 76.81 per hour work hours: 8am to 5pm education: Bachelors responsibilities: Support continuous improvement initiatives in product and process characterization.

Manage Non-Conformance (NC) reports: initiation, investigation, analysis, review, and closure.

Collaborate with third-party suppliers to resolve NC issues.

Conduct internal and supplier audits in compliance with ISO 13485 and 21 CFR 820.Develop and implement process control and monitoring methods based on risk assessment.

Collect and analyze statistical data to support process improvements and operational decisions.

Lead investigations and documentation of nonconformances, CAPAs, and customer complaints.

Ensure escalation of critical quality issues when appropriate.

Own and enforce material identification, segregation, and defect classification processes in manufacturing.

Evaluate the effectiveness of preventive and corrective actions.

Review and guide root cause investigations per established methodologies.

Skills:

Prior experience in manufacturing or operations is required.strong knowledge of FDA and ISO risk management practices.

Proven experience in risk mitigation and corrective action implementation.

Certified Internal Auditor for ISO 13485.Advanced knowledge in quality engineering principles and statistical methods.

Education and Experience:

Bachelor’s degree + 8 years experience,Master’s + 5 years, orDoctorate + 3 years. #LI-AG1 qualifications: Experience level:

ExperiencedEducation:

Bachelors skills:

QualityComplianceManufacturing Equal Opportunity Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.