Quality Specialist (Fort Worth, TX)

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

The Quality Engineer 2 role is responsible for ensuring manufacturing processes meet established quality standards. This involves developing, implementing, and monitoring quality control processes, conducting inspections and tests, analyzing data, and collaborating with various teams to identify and resolve quality issues. The incumbent will play a key role in creating and maintaining quality documentation, ensuring compliance with regulations, and contributing to continuous improvement initiatives.

This role is accountable for the Quality Risk Management program, the In-Process Control program, and the Periodic Review program for both equipment and manufacturing processes.

This role will require the incumbent to serve as a technical SME for providing inputs and approvals for various quality systems such as CAPA, Non-conformances, Work Orders, Change Controls, Complaints, and external and internal audits/inspections. Technical support will include but not limited to: Root Cause Analysis, Risk Management, and statistical analysis.

What will you be doing?

• Develop and maintain the Risk Management program for the site by periodically reviewing and updating Risk Assessment, as applicable.

• Develop and maintain the Periodic Review program for all manufacturing equipment and/or processes at the site by performing periodic assessments of the validated state of manufacturing equipment and/or processes. This will include re-validation of critical manufacturing processes.

• Provide technical support, reviews and approves SOPs, specifications, investigations, CAPA, Work Orders, Change Controls, and Complaints up to and including authoring documents and/or leading investigations, as applicable.

• Develop and maintain the IPC program for the site.

• Develop and lead one or more continuous improvement projects, ensuring technical alignment with the commercial and marketing strategy for the project and managing the project and project team to key milestones and targets.

• Performs other duties as required.

What will you need to be successful?

• Education:

  • Bachelor's degree required in engineering or related field preferred.

• License/certification: Relevant certifications preferred (e.g.: ASQ, CQE) Lean/Six Sigma certification preferred.

• Experience:

  • 3+ years of experience in a Pharmaceutical/Biotech environment or 2 years within the Quality Engineer 1 role with consistent performance.

  • Working knowledge in aseptic manufacturing and fermentation processes.

  • Hands on experience with validation/qualification of equipment and manufacturing processes.

• Knowledge of cGMP, ICH, and FDA guidance and regulations.

• Adherence to Quality Systems and Good Manufacturing Practices with proper attention to detail

• Demonstrated ability to work in a professional, multi-disciplinary, multi-cultural team as a group leader, facilitator, or participant.

• Ability to influence team members, peers, and senior managers.

• Strong analytical and troubleshooting skills.

• Ability to prioritize multiple projects along with multitasking.

• Effective verbal and written communication skills.

• Software: MS Project or Excel, Word, and PowerPoint

• Physical Demands: While performing the duties of this position, the Employee will be required to walk, stand, lift (up to 40 lbs), climb ladders/stairs, enter confined spaces, and work in high noise spaces.

• Travel Requirements: Up to 10% (international and domestic)

You. Unlimited

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

Inclusion and Belonging-Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more aboutEmployee Inclusion Groupson 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.