Hologic, Inc.
Quality Engineer II at Hologic, Inc. – join to apply for the role focused on validation, process improvement, and regulatory excellence across the manufacturing lifecycle of diagnostic and medical device products.
Overview
We are seeking a Quality Engineer II to ensure compliance and quality throughout the manufacturing lifecycle. You will lead validation efforts for analytical methods, equipment, processes, and facilities, drive risk management, and support regulatory submissions. You will collaborate cross-functionally, contribute to new product introductions, and champion process improvements in a fast-paced environment.
Responsibilities
Lead validation efforts for analytical methods, equipment, processes, and facilities. Drive risk analysis and implement risk-based validation strategies. Support regulatory submissions and maintain compliance with quality systems. Collaborate cross-functionally to develop PFMEAs and address process-related non-conformance events. Contribute to new product introductions and continuous process improvements. Provide guidance and mentorship to team members on validation and quality practices. Knowledge
Proficient understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment/facility qualification. Knowledge of risk analysis tools such as PFMEA and process risk assessments. Working knowledge of regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11. Familiarity with change control processes and documentation requirements. Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling plans. Skills
Strong technical writing skills for authoring validation protocols, reports, master validation plans, and regulatory submission content. Ability to perform validation impact assessments and determine risk-based validation strategies. Experience with electronic document management systems. Proficient in leading cross-functional teams to develop PFMEAs and address process-related non-conformance events. Excellent analytical and problem-solving skills to evaluate specifications and propose improvement projects. Strong interpersonal and collaboration skills to work effectively across departments and with cross-functional teams. Project management skills, including the ability to determine deliverables, set timelines, and manage departmental or cross-department projects. Behaviors
Detail-oriented and organized with a focus on accuracy and compliance. Proactive and solution-oriented, with a continuous improvement mindset to enhance processes and procedures. Collaborative team player who fosters strong partnerships across functions. Accountable and self-motivated, able to operate with limited supervision and escalate issues as needed. Committed to training and mentoring new employees to ensure team success. Adaptable and able to manage competing priorities in a fast-paced, regulated environment. Experience
2–5 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company. Hands-on experience with validation activities, including analytical method validation, process validation, and equipment/facility qualifications. Experience with regulatory submissions and understanding of quality systems in regulated industries. Practical experience with risk management, including PFMEAs and process risk assessments. Familiarity with change control processes and electronic document management systems. Compensation and Benefits
The annualized base salary range for this role is $78,300-$122,400 and is bonus eligible. Final compensation packages will depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Why join Hologic?
We are committed to making Hologic the destination for top talent. We provide comprehensive training when you join as well as continued development and training throughout your career. Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Medical Equipment Manufacturing Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement. Agencies may only submit candidates to positions for which they have been invited by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. Get notified about new Quality Engineer jobs in San Diego, CA.
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We are seeking a Quality Engineer II to ensure compliance and quality throughout the manufacturing lifecycle. You will lead validation efforts for analytical methods, equipment, processes, and facilities, drive risk management, and support regulatory submissions. You will collaborate cross-functionally, contribute to new product introductions, and champion process improvements in a fast-paced environment.
Responsibilities
Lead validation efforts for analytical methods, equipment, processes, and facilities. Drive risk analysis and implement risk-based validation strategies. Support regulatory submissions and maintain compliance with quality systems. Collaborate cross-functionally to develop PFMEAs and address process-related non-conformance events. Contribute to new product introductions and continuous process improvements. Provide guidance and mentorship to team members on validation and quality practices. Knowledge
Proficient understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment/facility qualification. Knowledge of risk analysis tools such as PFMEA and process risk assessments. Working knowledge of regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11. Familiarity with change control processes and documentation requirements. Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling plans. Skills
Strong technical writing skills for authoring validation protocols, reports, master validation plans, and regulatory submission content. Ability to perform validation impact assessments and determine risk-based validation strategies. Experience with electronic document management systems. Proficient in leading cross-functional teams to develop PFMEAs and address process-related non-conformance events. Excellent analytical and problem-solving skills to evaluate specifications and propose improvement projects. Strong interpersonal and collaboration skills to work effectively across departments and with cross-functional teams. Project management skills, including the ability to determine deliverables, set timelines, and manage departmental or cross-department projects. Behaviors
Detail-oriented and organized with a focus on accuracy and compliance. Proactive and solution-oriented, with a continuous improvement mindset to enhance processes and procedures. Collaborative team player who fosters strong partnerships across functions. Accountable and self-motivated, able to operate with limited supervision and escalate issues as needed. Committed to training and mentoring new employees to ensure team success. Adaptable and able to manage competing priorities in a fast-paced, regulated environment. Experience
2–5 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company. Hands-on experience with validation activities, including analytical method validation, process validation, and equipment/facility qualifications. Experience with regulatory submissions and understanding of quality systems in regulated industries. Practical experience with risk management, including PFMEAs and process risk assessments. Familiarity with change control processes and electronic document management systems. Compensation and Benefits
The annualized base salary range for this role is $78,300-$122,400 and is bonus eligible. Final compensation packages will depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Why join Hologic?
We are committed to making Hologic the destination for top talent. We provide comprehensive training when you join as well as continued development and training throughout your career. Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Medical Equipment Manufacturing Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement. Agencies may only submit candidates to positions for which they have been invited by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. Get notified about new Quality Engineer jobs in San Diego, CA.
#J-18808-Ljbffr