Quality Engineer (Columbia, MD)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Quality Engineer is responsible for providing technical and Quality support to Smith & Nephew AWB products during implementation, validation and commercialization. The Quality Engineer applies technical writing skills, statistical analysis, root cause analysis and investigation tools, knowledge of regulations, knowledge of biological and other tools to support development and manufacturing activities in a cGMP environment.

What will you be doing?

• This role will provide support for commercialized products and market expansion.

• This role will perform non-conformance and CAPA investigations to determine root cause and drive corrective actions.

• This role will write, review and execute validation protocols, reports and other technical studies, as required. This role will perform data analysis that includes use of statistical tools, including, but not limited to trending and sample size determination.

• This role will perform risk assessments including Hazard Analysis and FMEA utilizing standards such ISO 14971.

• This role shall be able to provide technical and quality support for various validation projects including shipping studies, stability studies, clean room validations, equipment (Lyophilizers, Autoclaves, Controlled Rate Freezers) validations, cleaning validations, microbial reduction and viral inactivation studies, process qualification and other validation types, as required.

• This role will write Standard Operating Procedures and Change Controls, as required.

• This role must have the ability to work independently and provide leadership to manufacturing technicians and other executors of authored protocols.

What will you need to be successful?

• Education:

  • Bachelor of Science degree in Engineering or scientific field required.

• License/Certifications: CQA preferred

• Experience:

  • 3 years of experience in medical human tissue product (HCT/P), medical device and/or pharmaceutical Quality Assurance, Quality Control, and/or Quality Engineering environment.

• Competence in both medical product design and manufacturing quality is essential, including process control and manufacturing quality engineering.

• Competence in quality management systems.

• Working knowledge of applicable quality system regulations including US, EU, and other major global/regional standards for tissue and/or medical device products.

• Fluent in statistical software (Excel, MiniTab, R); Fluent in Microsoft programs (Word, Excel, PowerPoint, Project and Visio), Strong written and verbal communication skills.

• Physical Demands: Office area and manufacturing shop floor exposure, be able to lift 25 lbs infrequently.

• Travel Requirements: 10-25%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.