Supplier Quality Microbiology Engineer (Mansfield, MA)

Davita Inc.; Mansfield (MA); Hybrid; USD 60,000 - 90,000; Full time

Job summary

A leading medical technology company is seeking a Supplier Quality Microbiology Engineer I to ensure the microbiological quality of materials and finished goods. The role involves auditing suppliers, regulatory compliance, and maintaining quality standards. Candidates should have a Bachelor's degree in Microbiology and 1-3 years of relevant experience in medical devices or pharmaceuticals.

Benefits

401k Matching Program

Tuition Reimbursement

Flex Holidays

Paid Community Service Day

Health Savings Account

Flexible Work Model

Qualifications

• 1 - 3 years of work experience in medical devices or pharma preferred.
• Knowledge of regulatory standards for microbiological testing.
• Experience with audit processes and compliance.

Responsibilities

• Ensure microbiological quality of raw materials and components.
• Support audits and compliance with sterilization standards.
• Act as a liaison between suppliers and the quality team.

Skills

Attention to Detail

Regulatory Knowledge

Microbiological Testing

Quality Control

Education

Bachelor of Science in Microbiology or Life Sciences

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 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 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/).

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

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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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