Quality Engineer 2

Hologic, Inc.; Marlborough (MA); On-site; USD 77,000 - 111,000; Full time

Job summary

Hologic, a leader in women's health, seeks a Quality Engineer 2 to provide engineering services for medical device manufacturing. The role involves compliance with ISO and FDA standards, data analysis, and project leadership for quality initiatives. This full-time position offers a competitive salary in an innovative environment focused on improving patient care.

Qualifications

• 2-4 years of experience as a Quality Professional in Medical Device industry.
• Must have relevant knowledge in quality engineering topics.
• Experience with Six Sigma, SPC, DOE advantageous.

Responsibilities

• Support Nonconforming Events investigation and related activities.
• Lead CAPA teams for corrective and preventive actions.
• Compile and analyze quality system metrics.

Skills

Knowledge of ISO 13485

FDA regulations

Computer literacy

Statistical tools

Education

Bachelor’s Degree in related discipline

Equivalent combination of education and experience

Job description

3 weeks ago Be among the first 25 applicants

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:
Provide Quality Engineering services and support for medical device product manufacturing, quality control, and new product development following all internal procedures and external regulations. The Quality Engineer 2 is provided direction from Management to execute within Quality Systems processes.
- Support Nonconforming Events investigation, disposition, and release activity.
- Compile and analyze quality system metrics (e.g., management review, compliance metrics, product quality assurance) in order to ensure Key Process Indicators are identified, measured, and reported. Identifies unfavorable trends and drives proportionate action.
- Lead CAPA teams to identify, investigate, and implement corrective and preventive actions .
- Lead projects related to New Product Introduction (NPI) and Transfers.
- Write, review, and/or approve reports for: Test Method Validation, Design Verification, Design Validation, and Process Validation (IQ, OQ, PQ).
- Write, review, and / or approved quality plans to support product and process compliance activities.
- Support Operational Excellence Initiatives.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
Education& Experience:
- Bachelor’s Degree in related discipline, or equivalent combination of education and experience.
- 2-4 years of experience as a Quality Professional in the Medical Device industry, or equivalent combination of education and experience
- Knowledge of ISO 13485, FDA regulations, and cGMP is required.
- Computer literacy is required.
Must follow all applicable FDA regulations and ISO requirements.
Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)
The annualized base salary range for this role is $77,900 to $110,400 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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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