Careers

Inspire and Commit to Each Other
Our personal integrity, trust of our colleagues, and dedication to our work creates
an environment of respect and excellence throughout Ameda.

This Ameda Core Value leads to a team-oriented culture where all are challenged to think beyond the obvious. If you have a desire to learn, grow and innovate, you can find purpose and satisfaction with us. At Ameda, you can make a contribution to an industry dedicated to improving the lives of mothers and babies.

There is no typical day at Ameda. Our market and our customers are always changing. This results in a highly stimulating atmosphere, where each employee can flourish based on his or her area of expertise.

Ameda is committed to creating opportunities for qualified, enthusiastic employees who want to broaden their skills. Our growth makes it possible to offer a spectrum of development options. We are interested in learning more about you. Resumes can be sent to Recruiting@ameda.com.

EEO/AA Employer

Current Opportunities

QUALITY ENGINEER

Job Title – Quality Engineer – Ameda

Location – Buffalo Grove, IL

Job Description:
Ameda, Inc is a leading producer of Class I and II medical devices supporting the retail and institutional Breastfeeding industry.  Due to increased growth, we are currently seeking a Quality Engineer to add to our staff in Buffalo Grove, IL

The Quality Engineer is a member of the Quality team and has the following responsibilities:

  • Execute CAPA investigations for product and process issues.
  • Perform complaint investigations.
  • Provide assistance in running CAPA review board.
  • Develop and/or monitor and analyze complaint metrics and open CAPAs as required.
  • Provide quality support for new product development, design changes, and risk management.
  • Assist in development and presentation of Management Review.
  • Develop return product testing requirements and procedures.
  • Develop test methods as required for product testing.
  • Provide guidance and assistance to laboratory techs in relation to product complaint issues.
  • Write and/or update procedures as required to ensure the quality system is compliant with all applicable regulations.
  • Work with clinical on completing MDR documentation for on-time submittal to the FDA.
  • Develop procedures for issue elevation for possible field action.

Required Experience:
Bachelor’s Degree in Engineering, or equivalent quality engineering work experience (5 - 8 years).

  • Medical device experience required.
  • 5 – 8 years experience as a Quality Engineer
  • Experience in medical device manufacturing operations.
  • Experience performing product investigations.
  • Experience with design control, change control, and risk management.

Required Knowledge, Skills and Experience:

  • Regulatory cGMP, QSR and ISO knowledge base as related to the medical device industry.
  • Extensive CAPA and problem solving experience.
  • Excellent English verbal and written communication skills.
  • Project management skills.
  • Proficient in Microsoft Office Suite (emphasis on Excel), Internet based tracking systems
  • ASQ Certification a plus.
  • Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
  • Must be able to identify and recommend effective solutions to problems, working individually and with others within and outside his/her function.

REGULATORY AFFAIRS SPECIALIST

Job Title:  Regulatory Affairs Specialist

Location – Buffalo Grove, IL

We are seeking an experienced regulatory affairs specialist to participate in and guide teams involved in the production, marketing, and distribution of Class I and II electromechanical devices and disposables to verify that all functions are operating according to regulations. The Regulatory Specialist must keep abreast of legislative developments in the countries or regions in which products are distributed, and advise and strategize with management, keeping them informed of the implications of regulatory developments and advising on methods to execute plans as needed. 

Responsibilities include: 

  • Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards
  • Compile and maintain 510(k), Technical File and other regulatory files, in a format consistent with requirements.Complete memos to file assessing changes.
  • Develop regulatory project plans, and align with global, regional and local marketing strategies.
  • Prepare, review, and approve labelling and SOP’s
  • Complete product and facility registrations, license extensions and amendments, renewals according to agreed timeline, and ensure approvals in a timely manner for regions in which Ameda distributes.
  • Maintenance of regulatory databases
  • Provide front and back room assistance for audits.
  • Provide support for responding to audits.
  • Maintain Health Canada regulatory licenses.
  • Maintain Certificates of Conformance for the EU.
  • Providing regulatory advice and support for new product development.

Experience

  • Min 5-8 years regulatory experience in medical device industry with products marketed in the US, EU, and Canada.
  • BS degree in a technical discipline.
  • Experience filing 510K and other submission packages.
  • Proficient in 21 CFR 820 and the Medical Device Directive, and Canadian Medical Device Regulations.
  • Working knowledge of FDA and international regulations.
  • Working knowledge of quality management systems.
  • Experience dealing with notified bodies.
  • Working knowledge of 13485 and CE mark requirements.
  • Working knowledge of MDR Reporting.
  • Experience conducting internal audits and writing audit responses.
Essential Skills
  • Sound basis of Regulatory and scientific knowledge
  • Attention to detail and commitment to
  • Ability to manage complex projects and timelines in a matrix team environment
  • Written and verbal communication and presentation skills
  • Ability to independently identify compliance risks and escalate when necessary
  • Thorough knowledge of applicable procedures, specifications, regulations and standards.
  • Organized in self, work and environment
  • Able to work in a matrix and cross-cultural environment
  • PC skills including Word, Excel, and interest and ability to learn other programs as required

 Competencies

  • Excellent interpersonal skills.
  • Proficient in technical writing and oral communication.
  • Experience researching regulatory requirements.
  • Ability to plan, execute, and complete projects in timeframes allotted.
  • Ability to work independently.

 Required Behavioral Competencies

  • Quality Orientation - Accomplishes tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checks processes and tasks; is watchful over a period of time.
  • Builds Strategic Working Relationships - Develops and uses collaborative relationships to facilitate the accomplishment of work goals.
  • Facilitates Change - Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitating the implementation and acceptance of change within the workplace.
  • Manages Work - Effectively manages one’s time and resources to ensure that work is completed efficiently.
  • Decision Making – Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
  • Initiates Action – Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
  • Contributes to Team Success - Actively participates as a member of a team to move the team toward the completion of goals.