Quality Engineer II

Duration: 06 months with possible extensionShift Hours: 8:30-5pm JOB DESCRIPTION:Quality Engineer 2 ensures Hologic’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. Through integrity, operational excellence, and a customer-focused mindset, the Quality Engineer 2 contributes to Hologic’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. Essential Duties and ResponsibilitiesThe incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.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 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 developmentCorrective and Preventitve Actions (CAPA) activitiesNew Product Introduction (NPI) and design transfer activitiesTest Method Validation (TMV) and Process Validation (IQ,OQ,PQ) execution Quality and engineering documentation/procedure development and change order technical reviewExcellence through Integrity, Compliance, Safety and EnvironmentEnsure compliance with all company policies and procedures, including safety regulations, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP).Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation.Actively contributes to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork.Engage in continuous improvement initiatives, striving for operational excellence and efficiency.Promote sustainable practices within the workplace, including waste reduction, recycling, and energy conservation.Participate as applicable in workshops, training sessions, and other activities aimed at fostering a culture of continuous improvement and lean thinking.Participate in regular training and complete all training on time. QualificationsEducation: Bachelor’s degree in engineering or related discipline, or equivalent combination of education and experience. Experience2-4 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. SkillsStrong 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 controlsClear 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. Physical Demands:The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.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.Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differentiEditing this field will affect all jobs at this hiring companyWho should get alert emails for new candidates?ators to comprehensively support your diverse workforce needs.Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities

Salary : $40 - $46