Quality Systems Engineer I/II – Test Method Validation

  • Permanent
  • Anywhere

Website Applied Medical

Applied Medical

Company : Applied Medical

Country: United States

Location : Rancho Santa Margarita, California

Post: Sat, 30 Jul 2022 21:43:00 GMT

Expires: Sat, 27 Aug 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————



Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 30 years and has earned a strong reputation for excellence in the healthcare field.  Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description:
As an Engineer I/II on the Quality Systems (QS) Team, you will be responsible for working within the framework of a team and performing the following activities:

Enhance product quality by developing and validating test methods that check for product performance and effectiveness

Work closely with the Product and Process Development teams to understand user needs, design and process requirements and test method acceptance criteria.

Develop clear and testable methods using technical standards and engineering principles

Design and create required test equipment

Complete test method validation and generate required protocols and reports

Investigate and document any anomalies found during testing, and propose solutions

Perform statistical analysis using tools like Analysis of Variance (ANOVA) and Gage Repeatability and Reproducibility (Gage R&R)

Write engineering reports to document the test results, data analysis, conclusions and recommendations.

Provide technical leadership and mentoring to team members

Collaborate and maintain excellent working relationships with team members and stakeholders

Interpret existing and emerging regulations, standards and guidance documents

Liaise with  internal and external customers

Meet or exceed customer expectations

Commit to continued quality improvements

Execute all activities in compliance with the quality system

Comply with safety regulations and company policies

Position Requirements:
This position requires the following skills and attributes:

Bachelor’s Degree or higher in Engineering or scientific field

Minimum of 1-year experience in medical device, healthcare or other regulated industries

Experience in test method development and validation

Basic understanding of statistical techniques

Experience in performing Gage R&R, ANOVA and measurement system analysis using MINITAB, or equivalent software

Self-motivated with strong problem-solving skills

Confidently work independently, as well as within a team setting

Effective oral and written communication and presentation skills

Strong technical writing capabilities

Proven problem-solving, organizational, analytical, and critical thinking skills with strong attention to details

Appropriately prioritize, multitask and organize tasks

As a healthcare company, it is of the utmost importance to keep our teams safe and healthy in this ever-changing COVID-19 environment. We require all new team members to be fully vaccinated (including booster shots, if eligible) upon their start date at Applied Medical (legitimate accommodation requests will be considered). Our current team members have also made this commitment to being vaccinated and receiving the booster shot to help protect each other, our families, our customers, and our visitors, as we work together to help end the pandemic. Eligibility details to receive the COVID-19 booster shot are provided on the CDC website .

The following skills and attributes are preferred:

Experience in Medical Device Quality Systems standards and regulations including ISO 13485 – Quality Management System, 14971 – Risk Management, MDR, 21CFR820 and other relevant standards

Experience in using Minitab, SolidWorks, or similar software

Experience in using SAP PLM or similar ERP system

Training and mentorship with ongoing learning and development courses

On-campus wellness activities

Comprehensive medical and dental and vision coverage

Education reimbursement program

401(k) program with discretionary employer match

Generous vacation accrual and paid vacation schedule

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.

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