Supplier Quality Microbiology Engineer (Mansfield, MA)

Smith & Nephew; Mansfield (MA); Hybrid; USD 70,000 - 90,000; Full time

Job summary

Smith & Nephew is looking for a Supplier Quality Microbiology Engineer I to join their quality team. The role involves ensuring microbiological quality compliance for materials supplied by vendors, driving continuous improvements, and evaluating supplier controls. Candidates need a Bachelor’s in Microbiology and relevant experience in the medical device industry.

Benefits

401k matching

Stock options

Tuition reimbursement

PTO and holidays

Medical, dental, and vision benefits

Employee assistance programs

Flexible work model

Mentorship programs

Qualifications

• 1-3 years in medical devices or pharma preferred.
• Knowledge of microbiological testing and regulatory standards is essential.
• Ability to assess audit outputs and develop action plans.

Responsibilities

• Ensure microbiological quality and compliance of raw materials and components.
• Evaluate supplier microbiological controls and support risk assessments.
• Assist in internal and external supplier audits.

Skills

Knowledge of regulatory standards

Microbiological testing

Environmental classification

Biological evaluation of medical devices

Education

Bachelor of Science in Microbiology

Related Life Sciences degree

Job description

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

We are seeking a detail-oriented and experienced Supplier Quality Microbiology Engineer I to join our dynamic quality team. In this role, you will be responsible for ensuring the microbiological quality and compliance of raw materials, components, and finished goods supplied by external vendors. You will evaluate supplier microbiological controls, support risk assessments, and ensure adherence to internal standards and regulatory requirements (e.g., FDA, ISO, USP). This position acts as a technical liaison between the company and its suppliers, driving continuous improvement and ensuring microbiological quality standards are met, with a focus on sterile CMO Contract Manufacturing and PFG Product Finished Goods suppliers, overseeing audits, continuous improvement, and transfer projects across all sterilization modalities and global sites.

**This position does not offer any visa transfer or sponsorship now or in the future.**

What will you be doing?

1. Collaborate with global microbiology and supplier quality teams to implement and maintain compliance of S+N sterile products from CMO/PFG suppliers.
2. Assess audit outputs and develop action plans to mitigate issues and maintain compliance with specifications and sterilization standards.
3. Support CMO/PFG Annual Desktop Audit assessments to ensure timely completion of all action items.
4. Assist in product transfers of sterile CMO/PFG suppliers to ensure compliance with sterilization standards.
5. Generate and follow through ECNs, MCOs, and NCRs to address process opportunities or noncompliance events.
6. Related to environmental control and sterilization processes.
7. Assist/performs internal and external supplier audits as required.
8. Comply with all requirements under our Quality Management System, including corrective and preventive actions, and adherence to regulations, policies, and procedures.
9. Implement standards and occupational health programs to ensure safety and recommend improvements to prevent incidents or illnesses.
10. Safeguard all documents, confidential information, equipment, tools, raw materials, and products to prevent incidents affecting productivity, safety, or compliance.

What will you need to be successful?

• Education: Bachelor of Science in Microbiology or related Life Sciences degree.
• Experience: 1-3 years in medical devices or pharma preferred.
• Knowledge of regulatory standards, microbiological testing, environmental classification, and biological evaluation of medical devices.
• Travel Requirements: Up to 10%.

You. Unlimited

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

Inclusion and Belonging: Committed to welcoming, celebrating, and thriving on inclusion and belonging. Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

Life at Smith+Nephew: We care for one another professionally and personally. Explore more about inclusion, diversity, equity, flexibility, and wellbeing at work.

Other reasons to love it here!

• Your Future: 401k matching, stock options, tuition reimbursement.
• Work/Life Balance: PTO, holidays, flex holidays, community service days.
• Your Wellbeing: Medical, dental, vision, HSA, employee assistance, parental leave, fertility and adoption support.
• Flexibility: Hybrid work model for most roles.
• Training: Hands-on, team-based, mentorship programs.
• Extra Perks: Discounts on fitness, travel, and more.

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Smith+Nephew provides equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.

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