Quality Engineer II

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 a Quality Engineer II, you will use your skills to support medical device quality through design controls, process validations and documentation as part of a cross-functional team.

 

Responsibilities

Conduct experiments to prove hypotheses

Create and validate test methods for design verification and manufacturing inspection testing by using measurement system analysis, gauge R&R and other relevant techniques

Implement statistical techniques to determine sample sizes and levels of confidence

Implement statistical process controls to monitor validated processes

Design engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reports

Perform root cause investigations for design and manufacturing

Document Non-Conformance Investigations (NCIR)

Document and implement Corrective and Preventative Actions (CAPA)

Generate protocols and reports for Installation, Operational and Performance Qualification (IQ, OQ, PQ)

Review engineering documents to ensure quality and compliance

Collaborate with design and manufacturing teams to assess device risk profile and failure modes in design (dFMEA) and manufacturing (pFMEA)

Position Requirements:
1-2 years of relevant work experience

Bachelor’s degree in an Engineering or STEM field or related education and experience

Experience in process verification and validation procedures

Exposure to ISO 9001 and ISO 13485

Exposure to CFR 21

Exposure to FMEA

Understanding of manufacturing, quality and risk management standards

Effective oral and written communication skills

Excellent technical writing

Ability to work effectively in cross-functional teams

Ability to read, analyze and interpret complex documents

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 .

Preferred:
Experience in the medical device industry

Working knowledge of statistics as it applies to verification testing and process control, and previous use of statistical analysis software, such as Minitab

Experience with project management tools (i.e. Microsoft Project)

Experience with software such as NetWeaver/Product Lifecycle Management 

Experience with leading a team or project

Benefits:
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.