Laboratory Technical Manager I at STERIS SOLUTIONS PTE LIMITED

Libertyville, Illinois, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Sep, 26

Salary

115000.0

Posted On

13 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Laboratory Compliance, Technical Leadership, Quality Assurance, Process Auditing, Proficiency Testing, CAPA Management, Method Validation, Data Trending, Regulatory Compliance, Stakeholder Collaboration, Technical Assessment, Change Control

Industry

Medical Equipment Manufacturing

Description

Position Summary This role serves as a strategic partner to Quality, ensuring laboratory compliance, technical excellence, and continuous improvement across regional laboratory operations. The position will develop and lead a team of Scientific Analysts with a strong focus on compliance. The role is responsible for supporting laboratory process audits, technical assessments, proficiency testing programs and driving appropriate corrective actions. It evaluates standards across regional laboratories, identifies gaps, and ensures timely closure through collaboration with the global technical team, laboratory operations and cross-functional stakeholders. A key aspect of the role includes monitoring and trending critical quality indicators such as out-of-specification results (OOS), nonconformances (NCs), change controls (CCs), deviations, and CAPAs. The position drives data-based insights and improvement initiatives in partnership with Lab Operations and quality. The role also contributes to global harmonization initiatives, supports Customer and regulatory audits, and facilitates onboarding of new analytical technologies and services. The position acts as a technical escalation point, supports Customer discussions, and represents the organization through external presentations and knowledge-sharing forums. It also plays a critical role in developing team capabilities by promoting technical growth, establishing best practices for method design and validation, and leading development programs such as trade-a-tech and technical learning initiatives. Overall, this position is pivotal in strengthening compliance, enhancing technical capabilities, improving Customer experience, and driving a culture of continuous learning and operational excellence across the laboratory network. What You'll Do as a Laboratory Technical Manager I Assure compliance Lead team of Scientific Analysts with compliance focus Responsible for coordination of lab process audits, with Quality, and technical assessments Responsible for coordination of proficiency testing, directing actions/improvements when appropriate Evaluate standards gap analysis for regional labs and close the gaps Evaluate trends in critical data and collaborate with lab ops for improvements. Manages Devs, CNs, NCs, CAPAs associated Monitor OOS’s, NC’s and CC’s for all labs, evaluating trends and directing action, when applicable Participate in harmonization activities, collaborating with lab ops to assure appropriate representation Supports Customer and Regulatory audits, where appropriate. Facilitates the onboarding of new analytical/technical equipment or services Supports global laboratory technical assessments Customer Experience Escalation point for Technical Customer discussions Presentations at webinars, seminars, etc., as appropriate, identifying and coaching others within the team Employee Technical growth Establish and maintain best practices for test method design for Customer product test method validations Facilitate the trade-a-tech program Sustain Lunch and Learn program with technical content, leveraging site resources Work with global technical on local representation on industry organizations The Experience, Skills, and Abilities Needed Bachelor's Degree. 5 years of experience in a Laboratory or medical device industry. 3 years of experience in a leadership role. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. Here is just a brief overview of what we offer: Market Competitive Pay Extensive Paid Time Off and (9) added holidays Excellent Healthcare, Dental and Vision Benefits Long/Short Term disability coverage 401(k) with company match Maternity & Paternal Leave Additional add-on benefits/discounts for programs such as Pet Insurance Tuition Reimbursement and continued educations programs Excellent opportunities for advancement and stable long-term career Pay range for this opportunity is $90,000 - $115,000. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

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Responsibilities

Lead a team of Scientific Analysts to ensure laboratory compliance, technical excellence, and continuous improvement across regional operations. Monitor critical quality indicators and drive data-based insights to resolve nonconformances and support regulatory audits.