Senior Quality Engineer| Manufacturing

Job highlights
Identified by Google from the original job post
Qualifications
Extensive Experience: Proven expertise in designing and maintaining advanced quality assurance protocols and methods
Analytical Excellence: Ability to conduct detailed analysis of reports and production data, identifying trends and recommending impactful changes
Regulatory Mastery: Deep knowledge of GLP, GMP, ISO, Six Sigma, and other relevant standards
Creative Problem-Solving: Demonstrated ability to resolve complex issues with innovative and effective solutions
Leadership and Coordination: Experience in leading and coordinating team activities, working collaboratively with cross-functional teams
Effective Communication: Strong communication skills to network with key contacts and drive quality initiatives forward
Bachelor's Degree in an Engineering concentration or related field
6+ years' experience Medical Device experience is a must
Advanced knowledge of ERP and PLM Systems, word processing, spreadsheet programs and databases
Ability to lead and motivate a high performing project team and supervise execution of projects, keep to timelines and prioritize resources
Excellent ability to read, analyze and interpret professional journals, technical procedures, and government regulations
Excellent collaboration and interpersonal skills
Advanced ability to analyze data and come to valid scientific conclusions
Very good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements
Ability to develop and deliver high quality presentations
Comprehensive knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma
Ability to simultaneously manage multiple large-scale projects in various lifecycle stages
Working knowledge of FDA and ISO regulations that govern the Medical Device is beneficial
Certified Quality Engineer is beneficial
Benefits
We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you
The annualized base salary range for this role is $114,800 - $17+,500 and is bonus eligible
Responsibilities
We are seeking a dynamic Senior Quality Engineer, Manufacturing to design, implement, and maintain cutting-edge quality assurance protocols and methods for transforming materials into exceptional finished products
This is your chance to make a significant impact on our manufacturing and production processes, ensuring compliance with the highest safety, quality, and regulatory standards for worldwide distribution
Innovative Quality Assurance:
Design, implement, and maintain groundbreaking quality assurance protocols and methods for processing materials into partially finished or finished products
Plan, implement, and manage compliance of manufacturing and production processes with both internal and external safety, quality, and regulatory standards
Precision Inspection and Testing:
Develop innovative methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, equipment, and finished products
Perform in-depth analysis of reports and production data to identify trends, driving continuous improvement and recommending updates to quality standards and procedures
Compliance Leadership:
Ensure unwavering compliance with in-house and external specifications and standards (e.g., GLP, GMP, ISO, Six Sigma)
Utilize your expertise and company objectives to creatively and effectively resolve complex issues
Complex Problem-Solving:
Tackle complex issues with thorough analysis, requiring an in-depth evaluation of variable factors
Exercise sound judgment in selecting methods, techniques, and evaluation criteria to achieve outstanding results
Leadership and Collaboration:
Determine and implement methods and procedures for new assignments, coordinating activities of other team members (Team Lead)
Network with key contacts outside your area of expertise to drive innovative quality initiatives
Adapts communication style to suit different audiences
Creates precise, accurate technical documentation
Able to facilitate group discussions
Job description
Are you a seasoned professional with a passion for ensuring top-notch quality standards? We are seeking a dynamic Senior Quality Engineer, Manufacturing to design, implement, and maintain cutting-edge quality assurance protocols and methods for transforming materials into exceptional finished products. This is your chance to make a significant impact on our manufacturing and production processes, ensuring compliance with the highest safety, quality, and regulatory standards for worldwide distribution. We are located in Newark, DE and will require onsite presence.

If you are ready to take on a thrilling and rewarding role that drives quality and innovation in our production processes, apply today and become a vital part of our mission to achieve unparalleled manufacturing and production excellence!

What You'll Do:
• Innovative Quality Assurance:
• Design, implement, and maintain groundbreaking quality assurance protocols and methods for processing materials into partially finished or finished products.
• Plan, implement, and manage compliance of manufacturing and production processes with both internal and external safety, quality, and regulatory standards.
• Precision Inspection and Testing:
• Develop innovative methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, equipment, and finished products.
• Perform in-depth analysis of reports and production data to identify trends, driving continuous improvement and recommending updates to quality standards and procedures.
• Compliance Leadership:
• Ensure unwavering compliance with in-house and external specifications and standards (e.g., GLP, GMP, ISO, Six Sigma).
• Utilize your expertise and company objectives to creatively and effectively resolve complex issues.
• Complex Problem-Solving:
• Tackle complex issues with thorough analysis, requiring an in-depth evaluation of variable factors.
• Exercise sound judgment in selecting methods, techniques, and evaluation criteria to achieve outstanding results.
• Leadership and Collaboration:
• Determine and implement methods and procedures for new assignments, coordinating activities of other team members (Team Lead).
• Network with key contacts outside your area of expertise to drive innovative quality initiatives.

What We’re Looking For:
• Extensive Experience: Proven expertise in designing and maintaining advanced quality assurance protocols and methods.
• Analytical Excellence: Ability to conduct detailed analysis of reports and production data, identifying trends and recommending impactful changes.
• Regulatory Mastery: Deep knowledge of GLP, GMP, ISO, Six Sigma, and other relevant standards.
• Creative Problem-Solving: Demonstrated ability to resolve complex issues with innovative and effective solutions.
• Leadership and Coordination: Experience in leading and coordinating team activities, working collaboratively with cross-functional teams.
• Effective Communication: Strong communication skills to network with key contacts and drive quality initiatives forward.

Qualifications:

Education And Experience
• Bachelor's Degree in an Engineering concentration or related field
• 6+ years' experience Medical Device experience is a must

Skills
• Advanced knowledge of ERP and PLM Systems, word processing, spreadsheet programs and databases
• Ability to lead and motivate a high performing project team and supervise execution of projects, keep to timelines and prioritize resources.
• Excellent ability to read, analyze and interpret professional journals, technical procedures, and government regulations.
• Excellent collaboration and interpersonal skills. Adapts communication style to suit different audiences. Creates precise, accurate technical documentation. Able to facilitate group discussions.
• Advanced ability to analyze data and come to valid scientific conclusions.
• Very good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements.
• Ability to develop and deliver high quality presentations.
• Comprehensive knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma
• Ability to simultaneously manage multiple large-scale projects in various lifecycle stages.
• Working knowledge of FDA and ISO regulations that govern the Medical Device is beneficial.
• Certified Quality Engineer is beneficial.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $114,800 - $17+,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so 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.

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