Job Description
Position Title: Quality Engineer II
Work Location: 445 Simarano Drive, Marlborough, MA, USA 01752
Assignment Duration: 6 months
Work Schedule: 8:30am – 5pm
Work Arrangement: Onsite
Position Summary
Quality Engineer 2 ensures the organization's medical device (capital equipment) manufacturing operations meets the highest quality standards by supporting manufacturing quality control and regulatory compliance.
Collaborating across teams, this role drives continuous improvement, maintains robust process controls, and delivers innovative solutions that uphold product quality, safety, and reliability.
Background & Context
Through integrity, operational excellence, and a customer-focused mindset, the Quality Engineer 2 contributes to the organization's Purpose, Promise, and Passion.
Foundations of Success:
The Quality Engineer 2 will exemplify the following principles:
Lead with Ownership: Lead with integrity and always aim to do the right thing. Be highly accountable, do what you say you're going to do, and take responsibility when things don’t go as planned. Be empowered to try new things and learn from mistakes.
Act with Speed: Maintain a strong bias towards action and getting things done with a sense of urgency. Ensure stakeholders are well-informed by regularly updating them early and often, avoiding unexpected surprises, even while operating at a rapid pace.
Foster Partnerships: Achieve goals through teamwork and collaboration. Invest in building and maintaining strong relationships with stakeholders, and work together to unite efforts in fulfilling organizational Purpose, Promise, and Passion.
Delight Customers: Consistently aim to delight customers by exceeding expectations, delivering exceptional experiences, and offering innovative solutions. Provide dedicated service, proactive communication, and a deep understanding of customers' needs to create lasting positive impressions and foster strong, trust-based relationships.
Celebrate Wins: Celebrate delivering impactful results. Build a team environment that others aspire to join by making a significant impact and celebrating achievements in a big way. Support team members and take pride in both individual and collective successes as a team of A-players.
Key Responsibilities
• This role will focus on supporting daily operations quality needs, such as: nonconforming event (NCE) investigations and rework approvals; equipment record review / out of tolerance investigations; containment / investigation of emerging issues in production, incoming inspection, and final release; and operational excellence activities.
• Lead NCE investigations to evaluate the impact of nonconforming materials on product quality and compliance. This includes determining appropriate containment actions, conducting root cause investigations, assessing risk, and collaborating with internal teams and cross-functional stakeholders to determine disposition and needed escalation activities. Drive timely disposition, release activities, and resolution efforts to ensure alignment with regulatory requirements and Quality System requirements.
• Monitor NCEs in order to identify trends and areas for improvement through data-driven decision-making. Address unfavorable trends proactively by initiating and driving proportionate corrective actions to maintain compliance, enhance product quality, and support continuous improvement.
• Assess equipment controls (validation, calibration, preventative maintenance, etc.), conduct out of tolerance investigations, and approve equipment records to ensure validity of manufactured devices.
• Support other Quality Engineering tasks on an as needed basis, such as:
• Process FMEA development
• Corrective and Preventitve Actions (CAPA) activities
• New Product Introduction (NPI) and design transfer activities
• Test Method Validation (TMV) and Process Validation (IQ,OQ,PQ) execution
• Quality and engineering documentation/procedure development and change order technical review
Qualification & Experience
• Bachelor’s Degree in Engineering or related discipline, or equivalent combination of education and experience.
• 2-4 years of experience as a Quality Professional in the Medical Device industry, or equivalent combination of education and experience.
• Experience with Class II and III Medical Device and/or IVD Device Capital Equipment is a plus.
• Strong knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, with the ability to ensure compliance and product quality.
• Proven ability to investigate and resolve quality issues, including Nonconforming Events (NCEs) and CAPAs, through root cause analysis and sustainable corrective actions.
• Knowledge of manufacturing equipment and equipment controls
• Clear understanding in risk management principles, including ISO 14971 and pFMEA, to support design transfer and production processes.
• Experience with statistical tools and methodologies like Six Sigma, SPC, and DOE for data analysis, process improvement, and trend monitoring.
• Strong technical writing and communication skills for preparing and reviewing technical documentation.
• Proficient in using Quality Management Systems (QMS), data analysis tools, and enterprise software systems, along with standard office applications.
Working Conditions & Physical Demands
• Sit; use hands or fingers, to handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 44.00/hr.