Quality Control Inspector 2

Hologic•Marlborough, MA

About The Position

So why join Hologic? You will have the opportunity to get in on the ground floor at a high growth facility to create a manufacturing process working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance you manufacturing operation skills and knowledge to further your career. The Quality Control Inspector is a critical member of the Quality Assurance team, responsible for ensuring that finished products and in-process components meet all regulatory, quality, and customer requirements before release to inventory. This role involves the meticulous review of Device History Records (DHRs), performing inspections, and providing support to manufacturing and quality processes, such as Incoming Inspection, Material Review Board (MRB), Calibration and Returned Material Authorization (RMA) activities. The Final Inspector 2 is instrumental in upholding Hologic’s commitment to excellence by ensuring compliance with Good Manufacturing Practices (GMP), ISO standards, and quality systems, while fostering a culture of continuous improvement and collaboration. What to expect: Lead with Ownership - Demonstrate integrity and always aim to do the right thing. Be highly accountable for your work, follow through on commitments, and take responsibility when things don’t go as planned. Embrace opportunities to try new things and learn from mistakes. Act with Speed - Approach tasks with a strong sense of urgency and a bias toward action. Keep stakeholders informed by providing regular updates early and often, ensuring transparency and avoiding unexpected surprises, even when working at a fast pace. Foster Partnerships - Collaborate effectively with teammates and stakeholders to achieve shared goals. Invest in building strong working relationships and contribute to efforts that fulfill the organization’s Purpose, Promise, and Passion. Delight Customers - Strive to exceed expectations by delivering high-quality work, exceptional experiences, and innovative solutions. Engage in proactive communication, provide excellent service, and develop a deep understanding of customer needs to create positive, lasting impressions and build trust-based relationships. Celebrate WINS! - Take pride in delivering impactful results. Contribute to a positive team environment by celebrating both individual and team accomplishments. Support colleagues, recognize collective successes, and embody the mindset of an 'A-player' who inspires others.

Requirements

High school degree and/or an equivalent technical school education preferred.
Minimum of 3 to 5 years related Quality Inspection experience in Medical Manufacturing environment.

Nice To Haves

Experience with Oracle, and Agile preferred.

Responsibilities

Perform detailed reviews of Device History Records (DHRs) as part of final inspection and release activities for finished products, ensuring accuracy and compliance with documentation standards.
Conduct reviews of manufacturing records for replacement components, subassemblies, and in-process inspections to ensure alignment with quality requirements.
Support manufacturing personnel by ensuring proper documentation of Failure Investigation Reports and processing of Non-Conforming Materials in the Product Lifecycle Management (PLM) system, including identification, quarantine, and documentation.
Perform routine inspections, including field service and special inspections, to support validations, studies, and incoming inspection activities.
Communicate and reinforce Good Manufacturing Practices (GMP) to manufacturing personnel to uphold quality standards.
Review and provide input on new releases of Inspection and Test documents to ensure adherence to Good Documentation Practices (GDP).
Maintain QA Activity Collection Plans, First Pass Yield reports, and other applicable tracking mechanisms to monitor quality metrics.
Collaborate with Engineering to provide feedback on documentation improvements and process changes.
Support Incoming, product returns and calibration teams as needed as needed.
Perform other duties as assigned by leadership to meet organizational and operational needs.