Why Hologic:
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.
What to expect:
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. Designs methods and procedures for 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).
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.
What we expect:
- 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. Collaborate and communicate effectively with junior level employees, peers and cross-functional teams across all levels of the organization.
- Collaborates with Operations, Engineering and R&D Accountable for ensuring that the products produced 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. Leads quality projects and will provide cost, schedule and resource needs for assigned projects. Responsible for monitoring and providing regular communication and updates on success factors such as progress, schedule, budget, project risks and resource of needs gaps. Ensure data, protocols and reports meet project objectives.
- Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry. Collaborates with other engineers and promotes learning, development and knowledge transfer. Mentors and coaches less senior staff.
- Provides technical expertise for Non-Conformance Events risk assessments and planned deviations.
- Author technical protocols, technical reports, and complaint investigation reports.
- 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 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.
- 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.
Education & Experience:
- 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.
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..
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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Must follow all applicable FDA regulations and ISO requirements.
Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)
