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MDR - Sr Quality Engineer - Exempt

Lancesoft

Dexter, MI

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JOB DETAILS
SALARY
$65
LOCATION
Dexter, MI
POSTED
3 days ago

Join our team in Dexter, MI, where you will be at the forefront of ensuring quality and compliance in the medical device industry. This role offers an exciting opportunity to work in a dynamic environment, supporting MDR remediation activities and ongoing manufacturing quality assurance for our diverse product lines.
Must Have:
  • 1-3 years of Medical Device industry experience
  • Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR)
  • Knowledge of standards: ISO 13485, ISO 14971, IEC 60601
  • Proficiency in Microsoft Office Applications (Word, Excel, Access, PowerPoint) and Windows OS
  • Experience in equipment IQ, OQ (Operational Qualification), and PQ (Performance Qualification) or process validation
  • Process Validation Lifecycle expertise
  • Preferred experience in DOE (Design of Experiments) with Minitab
  • Skills in Computer and Software Validation (CSV), SOP Development, and Change Control of Medical Devices
Nice to Have:
  • 1-3 years of Medical Device industry experience
Role Summary:
The Quality Engineer (QE) supports MDR remediation activities and ongoing manufacturing quality assurance for designated product families at the Dexter site. The role focuses on ensuring manufacturing processes, labeling, packaging, and documentation comply with internal quality standards and regulatory requirements. The QE collaborates closely with manufacturing, planning, warehouse operations, and product engineering to assess risks, implement process controls, and support product and process changes required for MDR compliance.
Day-to-Day Responsibilities:
  • Conduct First Article Inspections (FAIs) and complete associated documentation and reports.
  • Develop and maintain risk management documents (pFMEAs) and Control Plans for product families and technical files.
  • Conduct production floor observations and process tours to ensure risk assessments reflect current manufacturing practices.
  • Collaborate with manufacturing, quality, and product engineering teams to gather input for risk assessments and MDR updates.
  • Coordinate with MDD/product engineers to align on product family updates and MDR-related changes.
  • Perform packaging or fit testing and document results in formal reports.
  • Review, collaborate on, and approve manufacturing change orders.
  • Coordinate label printing and shipping activities with production line leads/supervisors and planning as needed.
  • Perform label verification and grading activities and generate associated reports.
  • Work with warehouse personnel to obtain components required for product testing and evaluations.
  • Maintain and manage documentation and change records within Agile PLM.
Top 3 Technical Skills Required:
  • Experience supporting, writing, and executing process validation and test method validations.
  • Experience creating and maintaining PFMEAs, Control Plans, and risk documentation aligned with medical device quality systems.
  • Experience performing FAIs, dimensional verification, and evaluating manufacturing or packaging changes.
Education and Experience Required:
Bachelor’s degree in Engineering (Quality, Mechanical, Biomedical, Industrial, or related field) and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience (experience in MDR highly preferred).
Work Schedule:
40 hours/week, onsite at Dexter, MI.
Additional Responsibilities:
Responsibilities may include developing, modifying, applying, and maintaining quality standards and protocols for processing materials into partially finished or finished materials product. Collaborating with engineering and manufacturing functions to ensure quality standards are in place. Devising and implementing methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Designing or specifying inspection and testing mechanisms and equipment;conducting quality assurance tests;and performing statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/