Quality Assurance Engineer 2

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.

The Quality Assurance Engineer 2 performs functions associated with quality systems and quality assurance operations, including working with all levels and functions within engineering, supply chain, regulatory, marketing, and all other business functions within the division to investigate process, product or quality system issues. Uses sophisticated programs to collect and evaluate data to assist in assessing and documenting results of quality assurance processes. Supports in the development and sustainability of methods and procedures for quality assurance and systems.

An experienced professional with a working knowledge and understanding of area of specialization; resolves a wide range of issues in creative ways. This includes, but is not limited to, supporting audit workstreams and/or FDA inspections as applicable. 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.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Has a working understanding of various aspects of the QMS and applies knowledge and skills to complete a wide range of tasks. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

What to expect:

• Model all quality values and supports 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.
• Responsible for the coordination of assigned Quality efforts and provides support for the Quality Assurance department as directed by the Quality Assurance Manager.
• Facilitates the following quality assurance functions: Periodic Review, Quality Planning, Quality Agreements, Corrective & Preventative Action program, process nonconformance, and administration Divisional Management Review.
• Provides guidance and expertise on investigation evaluation for nonconformances and monitors CAPA effectiveness post closure.
• Performs periodic reviews of quality processes including document ownership, nonconforming events, agreements, quality plans, and CAPA system to determine escalations and coordinates with departments to ensure adequate status resourcing.
• Owns and improves divisional various training and reference materials.

What we expect:

• Works on documentation and activities stemming from audits, management reviews, quality meetings, and divisional CAPA Review Board meetings.
• Serves as the divisional point of contact for various Quality processes for inputs to global process enhancements and training content.
• Participates in site internal and external quality audits including support of front and/or back room workstreams.
• Supports in audit preparation efforts including communicating with applicable functional areas and collecting data to ensure audit efficiency.
• Administrates the collection of divisional Management Review materials.
• Ability to modify, maintain, and create procedures and processes as applicable.
• Assisting in data analysis to develop key performance indicators for various functions.
• Reviews the sites open Quality Plans (QPL) and provides recommendations for updates.

Education and Experience:

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Technical Bachelors Degree
• Preferred Minimum Non-Technical Degree: 3-5 Years in medical device or IVD industry
• Preferred Minimum Technical/Advanced Degree: 2-4 Years with Technical Bachelors Degree, 1-3 Years with Masters Degree
• Experience with Agile or equivalent Product Lifecycle Management system is beneficial.

The annualized base salary range for this role is $76,000 to $120,000 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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