Quality Engineer

job summary:
A Quality Engineer is needed for an American medical technology company primarily focused on women's health, selling medical devices for diagnositcs, surgery, and medical imaging, in the Marlborough, MA area. This role requires a candidate with an engineering degree and 2 to 4 years of medical device experience to manage nonconforming event investigations, oversee equipment calibrations, and ensure regulatory compliance with ISO 13485 and FDA standards within a capital equipment manufacturing environment.

location: Marlborough, Massachusetts
job type: Contract
salary: $44 - 46 per hour
work hours: 8am to 4pm
education: Bachelors


responsibilities:

• Support daily manufacturing quality control and regulatory compliance for medical device capital equipment.

• Lead nonconforming event (NCE) investigations to evaluate the impact of materials on product quality and compliance.

• Determine containment actions, conduct root cause investigations, and assess risk for nonconforming materials.

• Collaborate with cross-functional stakeholders to determine product disposition and necessary escalation activities.

• Monitor quality data to identify trends and proactively initiate corrective actions to address unfavorable patterns.

• Assess equipment controls, including validation, calibration, and preventative maintenance.

• Conduct out of tolerance investigations and approve equipment records to ensure the validity of manufactured devices.

• Support process FMEA development and participate in Corrective and Preventive Action (CAPA) activities.

• Assist with New Product Introduction (NPI), design transfer, and the execution of process and test method validations.

• Review and develop quality and engineering documentation, procedures, and change orders.

• Ensure adherence to safety regulations, Standard Operating Procedures (SOPs), and Good Documentation Practices (GDP).

• Participate in continuous improvement and lean thinking initiatives to enhance operational efficiency.

Qualifications:

• Bachelor's Degree in Engineering or a related discipline, or an equivalent combination of education and experience.

• 2 to 4 years of experience as a quality professional specifically within the medical device industry.

• strong knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP.

• Experience with Class II and III medical devices or IVD device capital equipment is preferred.

• Proven ability to resolve quality issues through root cause analysis and sustainable corrective actions.

• Experience with statistical tools and methodologies such as Six Sigma, SPC, and DOE.

Other Requirements:

• Understanding of risk management principles, including ISO 14971 and pFMEA.

• Proficiency in using Quality Management Systems (QMS) and enterprise software systems.

• strong technical writing skills for preparing and reviewing complex technical documentation.

• Commitment to integrity, accountability, and a customer-focused mindset.

• Ability to operate with a sense of urgency and maintain proactive communication with stakeholders.

• Participation in regular training and a commitment to meeting all training deadlines.

• Alignment with company values regarding sustainability, inclusion, and operational excellence.

qualifications:

• Experience level: Experienced
• Education: Bachelors

skills: Quality


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 [email protected].


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.