Quality Engineer II

Location: Dexter

Quality Engineer II

Contract Role
Onsite~ Dexter Michigan
W2 Only

TECHNICAL SKILLS
Must Have
1. Experience in equipment IQ
2. Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
3. Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
4. Preferred experience in DOE (with minitab)

Other skills: 1. Computer and software validation CSV
2. SOP Development
3. Change control of Medical Devices
4. cConducted test method validation analysis
~Creating Control Plans
~Creating inspection sampling plans
~Developing packaging validation plans
~Develop the Risk Evaluation

Nice To Have
1-3 years medical Device

Role Summary
The Quality Engineer (QE) supports MDR remediation activities and ongoing manufacturing quality assurance for designated product families. 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 (e.g., carton dimension changes) 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.
Coordinate with MDD/product engineers to align on product family updates and MDR-related changes.
Perform packaging or fit testing (e.g., carton dimension changes) and document results in formal reports.
Review, collaborate on, and approve manufacturing change orders.
Maintain and manage documentation and change records within Agile PLM.

Top 3 technical skills that are required for the role:
1. Experience supporting, writing and executing process validation and test method validations.
2. Experience creating and maintaining PFMEAs, Control Plans, and risk documentation aligned with medical device quality systems.
3. Experience performing FAIs, dimensional verification, and evaluating manufacturing or packaging changes

Education Required: Bachelor's degree in Engineering (Quality, Mechanical, Biomedical, Industrial, or related field).
Years' Experience

Required:

Bachelor's Degree and minimum of 2 years of relevant experience, or advanced degree with a minimum of 1 years relevant experience (experience in MDR highly preferred)

Responsibilities may include the following and other duties may be assigned.

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

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