Quality Assurance Technician 1
Hologic
Quality Assurance Technician 1
Newark, DE, United States
We’re hiring aQuality Technicianto join our innovative team atHologic! In this role, you’ll support manufacturing operations by ensuring adherence to quality standards, monitoring nonconformance records, conducting audits, and driving compliance with regulatory procedures. If you’re detail-oriented, enjoy working in a collaborative environment, and are eager to grow your skills in the medical device industry, this could be the perfect opportunity for you!
**Knowledge**
+ Understanding of ISO 13485 standards (beneficial).
+ Familiarity with MDR and/or MDSAP regulatory frameworks (beneficial).
+ Knowledge of Standard Operating Procedures (SOPs) and Work Instructions (WIs) in manufacturing processes.
+ Awareness of Agile or Oracle systems (beneficial).
+ Basic knowledge of quality assurance processes in certified medical device or pharmaceutical manufacturing environments.
**Skills**
+ Ability to spot discrepancies and ensure accuracy in documentation and processes.
+ Strong ability to collaborate and interact with team members across all levels of the company.
+ Competence in MS Office, ERP systems, PLM databases, and reporting tools.
+ Ability to perform manufacturing process audits and ensure adherence to SOPs and WIs.
+ Support investigations related to non-conforming products and ensure timely resolution.
**Behaviors**
+ Thrives in routine tasks requiring structure and process understanding.
+ Works effectively with cross-functional teams and stakeholders to achieve quality goals.
+ Initiates and facilitates nonconformance records and ensures timely processing.
+ Maintains accurate training records and adheres to production schedules.
+ Promotes adherence to regulatory and quality standards.
**Experience**
+ 0–1 years of experience in a certified medical device or pharmaceutical manufacturing environment (beneficial).
+ Familiarity with Agile or Oracle systems is advantageous.
+ Certifications such as ASQ Calibration Technician, IPC-A-610, IPOC/WHMA-620, or J-STD-001 are beneficial but not required.
**Why join Hologic?**
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $40,200-$60,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, 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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