Engr Quality

USA SOLVENTUM US LLC; Brookings (SD); On-site; USD 124,000 - 171,000; Full time

Job summary

Solventum, Brookings, SD, seeks a Quality Engineer in QMS/Facilities to lead cross-functional validations, support requalification, and maintain QMS documentation. You will collaborate with project managers, sterilitiy teams, and maintenance to ensure compliant facility operations.

Requires a science/engineering/manufacturing bachelor's or equivalent, plus extensive experience in quality, validations, and regulatory standards relevant to medical devices and healthcare manufacturing.

Qualifications

• Bachelor's degree in science, engineering, or manufacturing and 7+ years in industry.
• Alternate: HS diploma with 12+ years in science/engineering/manufacturing.

Responsibilities

• Lead cross-functional facilities validations and qualification activities.
• Support requalification and contamination control programs.
• Develop and maintain QMS documents and procedures.
• Lead internal audits and manage CAPAs.

Skills

Quality engineering

Facilities validation

IQ/OQ documentation

CAPA management

Regulatory standards

Education

Bachelor's degree in science/engineering/manufacturing

High School Diploma/GED

Tools

ComplianceQuest

Job description

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/

3M Health Care is now Solventum. At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

As a Quality Engineer in QMS / Facilities, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Leading Cross Functional Facilities Validations / Qualification activities:
  • Writing / Performing IQOQ documentation for new or remodeled production areas and labs
  • Participate in Project facility design development process
• Supporting requalification process’ for facility related areas – such as HEPA filter through third parties
• Supporting any facility maintenance or contamination control activities: review / approval / verification
• Drafting, reviewing, owning, and approving Facility and QMS Documents/Procedures to compliance requirements.
• Working closely with project managers, global sterility assurance, production and maintenance teams to perform troubleshooting and resolve facility design or damage issues.
• Lead Internal audits and audit teams
• Create and Complete Audit reports in ComplianceQuest
• Create and Manage CAPAs associated with Internal or External audits
• Host / Participate in external audits when necessary
• Act as QMS SME for Plant questions or concerns with reference to Regulatory Standards
• Develop and Maintain Pest Management through QMS compliance regulations
• Identifies, plans, recommends, and completes quality programs involving innovative applications and extensions of existing and new technologies of major importance to division business.
• Maintains extensive network of resources (laboratory, manufacturing, engineering, sales and marketing) to facilitate completion of assignments.
• Independently performs project planning. Establishes project objectives and priorities. Maintains an awareness of quality improvement and product opportunities and is productive in evaluating ideas and making proposals.
• Documents results, observations and conclusions in approved electronic files and prepares reports to communicate results to appropriate personnel. May train, counsel, and guide technicians, technologists, operation personnel, and engineers. Functions as an effective team leader and promotes harmonious and efficient working relationships.
• The job also requires performing other duties as assigned. Percentages of time spent on job duties are estimates and may vary for each position

Your skills and experience

In order for you to succeed in this role from day one, Solventum requires (at a minimum) the following qualifications: Bachelor's degree in science, engineering, or manufacturing discipline and (7) seven years of experience in a private, public, government or military environment OR High School Diploma/GED from an accredited institution and a minimum of (12) twelve years of experience in science, engineering, or manufacturing in a private, public, government or military environment. In addition to the above requirements, the following are also required:

• Five (5) or more years of experience in engineering, validations, quality, or other technical role.
• Troubleshooting, Investigation, Remedial Action, and Analysis of Non-Conforming Facility related issues.
• Knowledge or certification in medical device industry regulations such as ISO 13485, ISO 9001, MDSAP, ANVISA, FDA QSR (21 CFR Part 11), and EU MDR.

Additional qualifications that could help you succeed even further in this role include:

• Validation experience / knowledge
• Professional quality certifications, such as Certified Quality Auditor (CQA), Certified Medical Device Auditor (CMDA), Certified Quality Engineer (CQE), or any others through American Society for Quality (ASQ) is preferred.
• Demonstrated project leadership abilities on highly technical and complex projects.

Location and Travel

Location: On site - Solventum Plant in Brookings, SD. Travel: Can include up to 10% [domestic or international] Relocation Assistance: No. You must be legally authorized to work in the destination country without the need for a work visa (e.g., H1B).

Supporting your well-being

Solventum offers many programs to help you live your best life, both physically and financially. To ensure competitive remuneration and performance, Solventum regularly compares itself with other companies of comparable size and scope. Applicable to US Applicants Only: The expected compensation range for this position is $124,000 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.).

Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Responsibilities

Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Recruitment Process and Policies

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

Terms of Use and Privacy Statement

Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here. Before submitting your application you will be asked to confirm your agreement with the terms.

About Solventum

A new healthcare company with a rich history. With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges. 20,000+ employees worldwide. Solventum relies on the courage and the boundless insights of professionals worldwide to achieve exceptional results for our customers and those who rely on them. Healthcare that leads with heart and humility starts with listening and never finishes, only evolves. As long as healthcare challenges remain unsolved, we will be here, united by empathy and a relentless belief that countless lives are improved through our work. Operations in 38 countries. Driven by our dedication to improved outcomes for all we serve, we break through by making unprecedented connections that impact lives. In more than 300 offices and facilities around the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders. To realize our shared vision, we harness diverse talents and perspectives from every background to not only address our customers' most urgent priorities but anticipate the needs of the future.