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Manager, Quality Engineering, Mid-Level
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Manager, Quality Engineering, Mid-Level
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Jobright.ai Get AI-powered advice on this job and more exclusive features. Jobright is an AI-powered career platform that helps job seekers discover the top opportunities in the US. We are NOT a staffing agency. Jobright does not hire directly for these positions. We connect you with verified openings from employers you can trust. Job Summary: Hologic, Inc. is seeking a Manager for Quality Engineering to lead a multidisciplinary team responsible for technical complaint investigations and continuous improvement of electromechanical in vitro diagnostics medical devices. The role involves ensuring the successful development and launch of safe and serviceable products while fostering a high-performing team culture. Responsibilities: • Manage a multidisciplinary team responsible for technical complaint investigations, root cause analysis, and continuous improvement for electromechanical in vitro diagnostics medical devices (IVDs). • Ensure the successful development and launch of safe, durable, and serviceable products. • Lead, mentor, and develop multidisciplinary teams of engineers and technicians. • Identify root causes, implement corrective actions, and drive continuous improvement. • Foster cross-functional partnerships with design, manufacturing, and service teams. • Develop and improve processes to maintain compliance, audit readiness, and efficiency. • Communicate effectively to foster a solutions-oriented team culture. • Maintain strong organizational and documentation skills with an emphasis on data-driven decision-making. Qualifications: Required: • Deep understanding of Quality Management Systems (QMS), including ISO 13485 and FDA QMSR regulations. • Expertise in root cause analysis, CAPA, complaint investigations, and systemic issue resolution. • Knowledge of 5S principles for lab organization and safety. • Familiarity with new product development processes and lifecycle management for medical devices. • Advanced knowledge of electromechanical and IVD medical device standards and best practices. • Proven ability to lead, mentor, and develop multidisciplinary teams of engineers and technicians. • Systematic approach to identifying root causes, implementing corrective actions, and driving continuous improvement. • Strong ability to foster cross-functional partnerships with design, manufacturing, and service teams. • Expertise in developing and improving processes to maintain compliance, audit readiness, and efficiency. • Excellent written, verbal, and interpersonal communication skills to foster a solutions-oriented team culture. • Strong organizational and documentation skills with an emphasis on data-driven decision-making. • Takes responsibility for team outcomes and follows through on commitments. • Passion for delivering innovative, proactive solutions that exceed customer expectations. • Values discipline, consistency, and quality at the source in all processes. • Actively seeks opportunities to drive meaningful change and deliver measurable results. • Demonstrates respect, teamwork, and open communication across all levels of the organization. • Upholds high ethical standards and fosters a culture of trust and accountability. • 7+ years of quality engineering experience in the medical device industry, with a focus on electromechanical and IVD devices. • Proven track record in complaint investigations, CAPA processes, and regulatory compliance. • Experience in a leadership or management role, with direct responsibility for engineering or technical staff. • Hands-on experience supporting new product development and launches. • Familiarity with managing laboratory or technical workspaces, including implementing 5S principles. • Experience supporting regulatory audits and maintaining audit-ready processes. Preferred: • Recognized certifications such as ASQ Certified Quality Engineer (CQE) are preferred but not required. Company: We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. Founded in 1985, the company is headquartered in Marlborough, Massachusetts, USA, with a team of 5001-10000 employees. The company is currently Public Company. Hologic, Inc. has a track record of offering H1B sponsorships. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Product Management Industries Software Development Referrals increase your chances of interviewing at Jobright.ai by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Quality Engineering Manager jobs in
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Manager, Quality Engineering, Mid-Level
role at
Jobright.ai 1 day ago Be among the first 25 applicants Join to apply for the
Manager, Quality Engineering, Mid-Level
role at
Jobright.ai Get AI-powered advice on this job and more exclusive features. Jobright is an AI-powered career platform that helps job seekers discover the top opportunities in the US. We are NOT a staffing agency. Jobright does not hire directly for these positions. We connect you with verified openings from employers you can trust. Job Summary: Hologic, Inc. is seeking a Manager for Quality Engineering to lead a multidisciplinary team responsible for technical complaint investigations and continuous improvement of electromechanical in vitro diagnostics medical devices. The role involves ensuring the successful development and launch of safe and serviceable products while fostering a high-performing team culture. Responsibilities: • Manage a multidisciplinary team responsible for technical complaint investigations, root cause analysis, and continuous improvement for electromechanical in vitro diagnostics medical devices (IVDs). • Ensure the successful development and launch of safe, durable, and serviceable products. • Lead, mentor, and develop multidisciplinary teams of engineers and technicians. • Identify root causes, implement corrective actions, and drive continuous improvement. • Foster cross-functional partnerships with design, manufacturing, and service teams. • Develop and improve processes to maintain compliance, audit readiness, and efficiency. • Communicate effectively to foster a solutions-oriented team culture. • Maintain strong organizational and documentation skills with an emphasis on data-driven decision-making. Qualifications: Required: • Deep understanding of Quality Management Systems (QMS), including ISO 13485 and FDA QMSR regulations. • Expertise in root cause analysis, CAPA, complaint investigations, and systemic issue resolution. • Knowledge of 5S principles for lab organization and safety. • Familiarity with new product development processes and lifecycle management for medical devices. • Advanced knowledge of electromechanical and IVD medical device standards and best practices. • Proven ability to lead, mentor, and develop multidisciplinary teams of engineers and technicians. • Systematic approach to identifying root causes, implementing corrective actions, and driving continuous improvement. • Strong ability to foster cross-functional partnerships with design, manufacturing, and service teams. • Expertise in developing and improving processes to maintain compliance, audit readiness, and efficiency. • Excellent written, verbal, and interpersonal communication skills to foster a solutions-oriented team culture. • Strong organizational and documentation skills with an emphasis on data-driven decision-making. • Takes responsibility for team outcomes and follows through on commitments. • Passion for delivering innovative, proactive solutions that exceed customer expectations. • Values discipline, consistency, and quality at the source in all processes. • Actively seeks opportunities to drive meaningful change and deliver measurable results. • Demonstrates respect, teamwork, and open communication across all levels of the organization. • Upholds high ethical standards and fosters a culture of trust and accountability. • 7+ years of quality engineering experience in the medical device industry, with a focus on electromechanical and IVD devices. • Proven track record in complaint investigations, CAPA processes, and regulatory compliance. • Experience in a leadership or management role, with direct responsibility for engineering or technical staff. • Hands-on experience supporting new product development and launches. • Familiarity with managing laboratory or technical workspaces, including implementing 5S principles. • Experience supporting regulatory audits and maintaining audit-ready processes. Preferred: • Recognized certifications such as ASQ Certified Quality Engineer (CQE) are preferred but not required. Company: We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. Founded in 1985, the company is headquartered in Marlborough, Massachusetts, USA, with a team of 5001-10000 employees. The company is currently Public Company. Hologic, Inc. has a track record of offering H1B sponsorships. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Product Management Industries Software Development Referrals increase your chances of interviewing at Jobright.ai by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Quality Engineering Manager jobs in
Marlborough, MA . Marlborough, MA $119,700.00-$199,400.00 5 days ago Marlborough, MA $130,000.00-$175,000.00 6 days ago Manager, Quality Assurance (QA), Global QMS
Senior Manager, Quality Engineering in Devens, MA
Suffolk County, MA $65,000.00-$80,000.00 6 days ago Quality Engineering Manager – Medical Device
Waltham, MA $129,300.00-$226,300.00 6 days ago Cambridge, MA $120,488.00-$192,780.00 4 days ago Senior Quality Engineer, Post Market (Hybrid - Acton, MA.)
Acton, MA $85,125.00-$127,687.50 2 days ago Manager, Quality Assurance Technical Operations - Investigations
Northborough, MA $145,000.00-$182,000.00 13 hours ago Newton, MA $150,000.00-$225,000.00 5 days ago Quality Assurance Specialist/Manager – Bioanalytical Laboratory
Assurance Manager, Quality Management - IS Assurance
Boston, MA $85,000.00-$115,000.00 18 hours ago Quality Assurance Engineer (Hybrid - Acton, MA.)
Acton, MA $68,700.00-$103,050.00 4 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr