Quality Engineer

Newark, DE, United States

Join Our Team as a Quality Engineer!

Are you passionate about quality and eager to make a difference? We're looking for a dynamic Quality Engineer to dive into exciting challenges and help us maintain the highest standards of excellence. If you love problem-solving and want to be part of a team that values innovation and collaboration, this could be the perfect role for you. Apply today!

What to Expect:

In this role, you can expect to support evaluations, investigations, and root cause analyses to uncover the story behind post-market feedback and field complaints. You'll also be the hero who assists in processing and evaluating product returns, ensuring everything meets the highest standards and regulations.

As the Quality Engineer, you'll support the complaint process from start to finish, ensuring each complaint is valid, well-documented, and properly coded. Your keen analytical skills will come into play as you prioritize complaint processing and investigations based on product risk, data trends, and strategic impact. Your decisions will make a real difference!

You can expect to work with awesome teams to support implementing improvements and corrections based on your investigation results. Your input will help us continuously improve and innovate!

What We Expect:

• Provide visibility to the status of INVs, CAPAs, and SCARs and track to completion.

• Prepares agendas, leads meetings and completes action items.

• Maintains investigation lab, including product, test equipment, and procedures.

• Partners with TS or Field Service to ensure appropriate required information is documented in complaints to aid in product investigations.

• May provide support during inspections by regulatory bodies, with regards to documentation of product quality investigations.

• Work closely with R&D, Manufacturing, Service, and Supplier Quality to ensure thorough and accurate investigations and drive the initiation and execution of CAPAs when appropriate.

• Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.

• Communicates pertinent quality topics to the field.

• Responsible for supporting the complaint processing from initiation through closure.

• Support minor to moderate complaint trending, risk management, defect investigation, product investigation and corrective action activities.

• Observes and participates with cross-functional teams on quality projects, including pulse of the field through PAC/service councils.

• Supports assigned department metrics and leads projects or initiatives to reach departmental goals.

• Responsible for post-market product expertise, including clinical workflows.

Qualifications and Skills

Education

• Bachelor’s in Engineering (mechanical / biomedical/ Biomechanical / Electrical)

Experience

• Preferred Minimum Non-Technical Degree: 1-3 Years

• Preferred Minimum Technical/Advanced Degree: 0-2 Years with Technical Bachelor’s Degree, 0-2 Years with Master’s Degree

• Experience in an FDA regulated industry is beneficial.

• Experience with cleanroom processes is beneficial.

Skills

• Strong collaboration and interpersonal skills.

• Excellent computer skills including ability to use word processing, spreadsheet programs and database

• Excellent technical writing skills with ability to write quality assurance reports and details procedures.

• Excellent problem solving and root cause analysis skills (use of root cause analysis tools).

• Strong analytical skills including trend and statistical analysis.

• Ability to actively participate on the execution of projects, keep to timelines and prioritize activities.

• Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements is beneficial.

• Certified Quality Engineer is beneficial.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $52,400 - $81,900 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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