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Quality Engineer 2

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Hologic, Inc.

Feb 6

  • Job
    Full-time
    Mid Level
  • Engineering
    Healthcare
  • Redwood City

AI generated summary

  • You need a Bachelor’s in Mechanical, Biomedical, Biomechanical, or Electrical Engineering and 3 years of experience. FDA experience and skills in root cause analysis or R&D are beneficial.
  • You will evaluate complaints, conduct root cause analyses, process product returns, lead cross-functional teams for improvements, and present quality metrics while collaborating with various departments.

Requirements

  • Education & Experience:
  • Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 3 years experience
  • Experience in an FDA regulated industry is beneficial.
  • Experience in root cause analysis or product development/R&D is beneficial.

Responsibilities

  • Performs evaluations, investigations, and root cause analyses in relation to post market feedback and complaints from the field.
  • Responsible for processing and evaluating product returns for manufactured and distributed products as required by applicable regulations, standards, and internal procedures.
  • Processes and owns complaints as a facilitator from initiation to closure to ensure validity of the complaint and adequate information and codes are assigned to the records.
  • Provide input in prioritization of complaints and investigations based on product risk, data analysis and trending, and strategic impact.
  • Lead cross functional team in implementation of improvements or corrections based on the results of complaint investigations.
  • Work on complex electromechanical device with software and hardware.
  • Works with intermediate level of autonomy and independence, requiring minor oversight on complex problems with analysis requiring a variety of factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.
  • Performs investigations in the field at customer sites partnering with field-based teams, including sales and service.
  • As applicable, lead project to implement design or process change including drawing update, fixture and tooling update, performing testing and change control documentation.
  • Partner with cross functional team and communicate root cause, recommended changes and scope effort to implement changes as needed.
  • Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
  • Own Investigations and work with cross functional teams to determine if CAPA is required.
  • Conduct timely analysis of data, development/execution investigative plan.
  • Partners with Field Service and Technical Support for required documentation.
  • Work closely with R&D, Manufacturing Operations, Service, and Supplier Quality.
  • Customer site visits as needed.
  • Present product quality metrics to Leadership, explain root cause, and recommend actions/resolutions.
  • Supports monthly Quality Investigation Review boards.

FAQs

What qualifications are required for the Quality Engineer 2 position?

A Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering is required, along with 3 years of experience.

Is experience in an FDA-regulated industry important for this role?

Yes, experience in an FDA-regulated industry is beneficial for this position.

What type of analyses does the Quality Engineer 2 perform?

The Quality Engineer 2 performs evaluations, investigations, and root cause analyses related to post market feedback and complaints.

Will the Quality Engineer 2 be required to visit customer sites?

Yes, customer site visits are needed as part of the role.

What is the expected salary range for the Quality Engineer 2 position?

The annualized base salary range for this role is $78,000 to $118,400, and it is bonus eligible.

Are there opportunities to work with cross-functional teams in this role?

Yes, the Quality Engineer 2 will work closely with cross-functional teams including R&D, Manufacturing Operations, Service, and Supplier Quality.

What are the primary responsibilities of the Quality Engineer 2?

Responsibilities include performing investigations, processing and evaluating product returns, leading cross-functional teams, and presenting product quality metrics to leadership.

Are there any specific skills related to product development or root cause analysis that are beneficial for this role?

Yes, experience in root cause analysis and product development/R&D is beneficial for this position.

Will I need to work independently in this role?

Yes, the Quality Engineer 2 works with an intermediate level of autonomy and independence, requiring minor oversight on complex problems.

Does Hologic have a commitment to diversity and inclusion?

Yes, Hologic is proud to be an Equal Opportunity Employer, inclusive of disability and veterans.

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Hologic, Inc.

Enabling healthier lives, everywhere, every day.

Manufacturing & Electronics
Industry
5001-10,000
Employees
1985
Founded Year

Mission & Purpose

We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day. While we discover and develop groundbreaking products and services that benefit everyone, we are especially passionate about those that advance women’s health and well-being. This allows us to be a company that prospers, grows and empowers women to experience healthier lives. None of this would be possible without the talent, skills and aspirations of our employees. Their expertise and dedication to developing and sharing more robust, science-based certainty drives our increasingly global presence, as well as a pipeline that responds to the unmet health and wellness needs of women, families and communities. What powers our growth across Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions is also what differentiates us: the exceptional and clinically proven ability 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 always challenging ourselves to improve health through better technology, education and market access. Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses. We work toward this goal every day, always aware that in an increasingly complex and competitive global environment, we must continually earn the trust of our customers and their patients. By focusing on women’s health while still delivering health benefits to everyone, we are setting a new standard of excellence that is strengthened by purpose, driven by passion and brought to life by our promise of more certain early detection and better health outcomes.

Benefits

  • Healthcare

    When you feel good, you are at your best every day. Our comprehensive healthcare benefits include a cycle to work scheme, gym subsidy and dental plan options. Plus, lifestyle advice and tax-favourable savings accounts to help you and your family receive the care you deserve when you need it most.

  • Pension

    Relax into your retirement with a personal pension plan. On this defined contribution scheme, you will contribute 3% and we will double that and contribute 6%.

  • Insurance

    We understand the importance of safeguarding your income now and in the future. That is why we offer a variety of Insurances including, Short- and long-term disability and very competitive life Insurance. We also offer Vitality health insurance for you, with the option to add any dependents at your own cost.

  • Wellbeing

    From our free and confidential Employee Assistance Programme to advice and support around self-care or time away from work, we have all the tools and resources you need to help manage the demands of life and family - to achieve the healthiest and happiest life you can.

  • Fuel

    To stay in top shape, we need to fuel our bodies. Most of our countries in Europe allow for meal subsidies, be it in the form of discounted cafes on site or through Luncheon voucher schemes.