Supplier Quality Microbiology Engineer (Mansfield, MA)

Smith+Nephew; Mansfield (OH); On-site; USD 58,000 - 75,000; Full time

Job summary

A leading company in medical equipment manufacturing seeks a Supplier Quality Microbiology Engineer. The role involves ensuring the microbiological quality and compliance of components and raw materials, along with conducting audits and supporting risk assessments. Candidates should have a B.S. in Microbiology and 1-3 years of relevant experience, with an emphasis on regulatory knowledge and collaboration with global teams.

Benefits

401k Matching Program

Tuition Reimbursement

Medical, Dental, Vision Insurance

Paid Time Off

Hybrid Work Model

Qualifications

• 1 - 3 years of work experience in medical devices or pharmaceuticals preferred.
• Experience and knowledge of regulatory standards and guidelines for microbiological testing.

Responsibilities

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

Skills

Attention to Detail

Regulatory Knowledge

Quality Assurance

Education

Bachelor of Science in Microbiology

Life Sciences degree

Job description

Supplier Quality Microbiology Engineer (Mansfield, MA)

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Supplier Quality Microbiology Engineer (Mansfield, MA)

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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 play a key role in evaluating supplier microbiological controls, supporting risk assessments, and ensuring adherence to internal standards and regulatory requirements (e.g., FDA, ISO, USP). This position serves as a technical liaison between the company and its suppliers, driving continuous improvement and ensuring that microbiological quality standards are consistently met. Focusing on supplier quality for sterile CMO Contract Manufacturing and PFG Product Finished Good suppliers for oversight and completion of audits, continuous improvement and new transfer projects for all sterilization modalities and across all global sites.

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

What will you be doing?

• Will work with global microbiology and supplier quality to implement and maintain compliance of S+N sterile products from CMO/PFG suppliers
• Work and collaborate with global microbiology and other teams as needed to assess audit output and to put together action plans to mitigate and maintain compliance to established specifications and sterilization standards.
• Support CMO/PFG Annual Desktop Audit assessments to ensure completion of all action items by established deadlines.
• Assists in product transfers of sterile CMO/PFG suppliers to ensure compliance with sterilization standards and established specifications.
• Generates and follows through ECNs, MCOs, and NCRs to address process opportunities or noncompliance events.
• related to environmental control and sterilization process.
• Assists/performs internal and external supplier audits as required.
• Complies with all requirements, duties and obligations under our Quality Management System. This includes the proper action program Management well as corrective and preventive strict adherence and compliance to all regulations, policies and quality procedures.
• Complies with the implementation of standards and occupational health programs established by the company, through a compliance with those recommendations to perform the work safely and also advise the company on improvements to prevent incidents or illnesses that could actually damage the integrity of workers and / or the facilities and assets of the company.
• Responsible for safeguarding all documents, confidential information, equipment, tools, raw materials, products or other assets directly related to their field of work, in order to avoid incidents that affect the productivity and distribution of our products that may cause economic impact for the company or a breach with our customers, suppliers, shareholders and / or other key audiences.
  
  
  

What will you need to be successful?

• Education: Bachelor of Science in Microbiology or other Life Sciences degree required.
• Experience: 1 - 3 years of work experience (medical devices or pharma preferred)
• Experience and knowledge of regulatory standards, reference standards, guidelines for microbiological testing, classification and monitoring of environmental controlled areas and biological evaluation of medical devices.
• Travel Requirements: Up to 10%
  
  
  

You. Unlimited

We believe in creating the greatest good for society. Our strongest 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: At Smith+Nephew, we care for one another professionally and personally. Find out more about inclusion, diversity and equity, flexibility, and wellbeing at work.

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.

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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