Quality Engineer 3

About the role

Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.

Responsibilities

• Responsible for designing, inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
• Collaborates with Operations, Engineering and R&D to ensure products meet applicable regulatory and quality standards and customer expectations.
• Accountable for the development, training delivery and monitoring of procedures, investigation procedures and test methods in compliance with QMS, Medical Device Quality System Regulation and Medical Device Directive requirements.
• Acts with urgency to identify and lead the timely resolution of quality issues.
• Lead moderate to complex risk management, defect investigation, customer complaint investigation and corrective action activities.
• Lead quality projects and provide cost, schedule and resource needs for assigned projects.
• Mentor and coach less senior staff.
• Author technical protocols, technical reports, and complaint investigation reports.
• Review technical publications, articles and abstracts to stay abreast of technical developments in the industry.
• Responsible for processes such as MRB, NCE, CAPA and SCAR process.
• Responsible for the review and approval process for ECO’s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation.
• Responsible for compliance required facility and supplier audits and Notified Body and FDA inspections.
• Executes analysis of large datasets. Analyze associated lines of investigation and devise and recommend methods to resolve problems.

Requirements

• Model all quality values and coaches others on BSH quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement.
• Collaborates and communicates effectively with junior level employees, peers and cross-functional teams across all levels of the organization.
• May participate in external collaborations.
• May present results and progress for management and key external customer review.
• Identify and recommend improvements to the organization, processes, procedures and the Quality Management System.

Qualifications

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree
• Preferred Minimum Non-Technical Degree: 5-8 Years
• Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor’s Degree, 1-3 Years with Master’s Degree, 0-1 Years with PhD
• Experience with sterilization and cleanroom processes is beneficial.

Skills

• Strong analytical skills.
• Excellent problem-solving abilities.
• Effective communication and collaboration skills.
• Ability to manage multiple projects simultaneously.
• Knowledge of FDA regulations and ISO requirements.

Benefits

Annualized base salary range for this role is $97,000 to $152,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Pay

The annualized base salary range for this role is $97,000 to $152,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Schedule

Not specified.

Company Information

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.

Equal Opportunity Employer

Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)

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