Quality Assurance Engineer 2 - Hologic
Newark, DE
About the Job
Quality Assurance Engineer 2
Newark, DE, United States
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.
Our innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses and other health conditions earlier and more effective.
Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.
What to expect:
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 a 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 we 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: Corrective & Preventative Action program, process nonconformance, and administration Divisional Management Review.
+ Provides guidance and expertise on root cause evaluation and monitors CAPA effectiveness post closure.
+ Performs daily reviews of the CAPA system to determine escalations and coordinates with departments to ensure adequate resourcing.
+ Owns and improves divisional CAPA toolbox which includes training and reference materials.
+ Works on documentation and activities stemming from the site CAPA Review Board meetings.
+ Serves as the divisional point of contact for the CAPA process and provides 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
Education & Experience:
+ Preferred Minimum Non-Technical Degree: College Degree
+ Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s 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 Bachelor’s Degree, 1-3 Years with Master’s Degree
+ Experience with Agile or equivalent Product Lifecycle Management system is beneficial
The annualized base salary range for this hourly role is $74,500 to $116,600 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._
#LI-PR1
Newark, DE, United States
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.
Our innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses and other health conditions earlier and more effective.
Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.
What to expect:
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 a 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 we 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: Corrective & Preventative Action program, process nonconformance, and administration Divisional Management Review.
+ Provides guidance and expertise on root cause evaluation and monitors CAPA effectiveness post closure.
+ Performs daily reviews of the CAPA system to determine escalations and coordinates with departments to ensure adequate resourcing.
+ Owns and improves divisional CAPA toolbox which includes training and reference materials.
+ Works on documentation and activities stemming from the site CAPA Review Board meetings.
+ Serves as the divisional point of contact for the CAPA process and provides 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
Education & Experience:
+ Preferred Minimum Non-Technical Degree: College Degree
+ Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s 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 Bachelor’s Degree, 1-3 Years with Master’s Degree
+ Experience with Agile or equivalent Product Lifecycle Management system is beneficial
The annualized base salary range for this hourly role is $74,500 to $116,600 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._
#LI-PR1
Source : Hologic