Quality Systems Specialist (Columbia, MD)

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

The Quality Systems Specialist is primarily responsible for conducting investigations into nonconformances, CAPAs, and complaints.

What will you be doing?

• Conduct nonconformance investigations within specified timelines to identify root cause.

• Perform and document risk assessment of the nonconformance in relation to product/material impact.

• Perform and execute disposition of product/material related to nonconformances.

• Determine and execute corrective and preventive actions plans related to root cause determination for nonconformances.

• Perform and report nonconformance tracking and trending metrics to ensure trends are being identified and nonconformances are closing on time.

• Conduct and assist with CAPA investigations using root cause investigation tools (e.g. 5 Whys, Fishbone).

• Perform and monitor implementation activities related to CAPA action plans and track CAPA effectiveness.

• Assist with complaint investigations, inspection of any returned product related to complaints, and conduct of adverse event investigations.

What will you need to be successful?

• Education:

  • Bachelor of Science degree required.

• Experience:

  • 3 years of experience in a regulated biotechnology or pharmaceutical environment that includes investigation experience.

• A working understanding of Good Tissue Practices (GTP) or Good Manufacturing Processes (GMP) and Quality Systems. 

• Demonstrated competence in quality management systems related to nonconformances and change control. 

• Experienced with Microsoft programs (Word, Excel, PowerPoint, Project, and Visio).

• Strong written and verbal communication skills

• Knowledge of quality management standards (ISO 13485)

• Technical writing experience

• Physical Demands: Office area, warehouse area, controlled temperature storage areas

• Travel Requirements:  0-5%

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients 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

• Flexibility: Hybrid Work Model (For most professional roles)

• 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.