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Regulatory & Quality Assurance
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
 
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
 
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
 
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
 
 
Duties & Responsibilities:
  • Provides Quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, risk management and specification development.
  • Provides ongoing quality engineering support throughout the product lifecycle, for example design changes and product complaints/field corrections.
  • Assists team with determining validation needs based on risk.
  • Supports audits and inspections and external customer audits for design Controls and risk management.
  • Creates Quality plan, risk assessments and/or remediation plans.
  • Identifies and leads/supports process improvement opportunities.
  •  Applies experience and knowledge of regulations and standards to manage the risk and provide solutions/ strategy.
  • Develops/updates process procedures and other controlled documents.
  • Leads dept. and cross-dept. projects
  • Assists in developing and implementing policies
  • Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.
  • Demonstrated experience in the effective application and meeting requirements of FDA 21 CFR Part 820 QS regulations and ISO 13485/ 14971 standards, as well as CE regulations.
  • Strong influencing and negotiation skills
  • Experience with quality and process improvement methodologies and tools Knowledge of  validation methods & evaluation criteria
  • Advanced knowledge of design control, change control, QC, manufacturing & inventory
  • Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP), manufacturing execution systems (MES).
  • Experience with enterprise Quality System tools (e.g., electronic CAPA, Complaint Management systems)
  • Working knowledge of statistical principals of DOE, ANOVA, Cpk, etc.
  • Understanding of engineering drawings and symbols
  • Good knowledge of sampling plans
 
 
Education:
  • BS or equivalent in an engineering or life science discipline.
Experience:
  • Typically with 5- 7 years of related experience.
  • Experience working in a regulated environment,  in-vitro diagnostics preferred
  • Quality Certification preferred (e.g., CQE, CQA, SQE, 6-Sigma, Lean)
  • Advanced knowledge of scientific principles and concepts.
 
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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