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MDR - Sr Quality Engineer - Exempt

3 months ago

Louisville, Kentucky, United States LanceSoft Full time
Must Have:1. Experience supporting, coordinating and / or leading projects 2. Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA) 3. Experience in development of new or existing medical devices 4. Knowledge of industry standards (ISO and regulations, specifically EU MDR and UKCA1. Investigation and root cause analysis skills 2. Technical writing knowledge. Organization and Communication skills 3.

Process Validation and Computer software validation knowledge3+ years of surgical medical device product manufacturing experience that includes:
o qa responsi5+ years of experience supporting new product development activities in medical deviceNice to Have:1. Investigation and root cause analysis skills, 2. Technical writing knowledge, 3. Organization and Communication skills, 4.

Process Validation and Computer software validation knowledgeJOB DESCRIPTIONThe Primary function of this position is to support Operations Quality on New Product Launches and a large labeling project.

In this role, you will rewiew and approve validations (process, software, equipment) You will work hand in hand with Manufacturing Enigineering to develop Operator Work Instructions and set up assembly stations.

You will work directly with Inspection Inspection to help establish inspection methods of new incoming components and assist in resolving inspection issues.

In addtion to the primary task, 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.

Ideal candidate will be a seasoned individual contributor that works independently under limited supervision. Candidate should be able to successfully navigate between project work and addressing the day to day needs of manufacturing. Candidate should be comfortable reviewing and approving Software, Process and Equipment Validations. Candidate should be able to coach and influence other Manufacturing Engineer to ensure compliance with Quality Requirements. Requires a 4 year degree in Engineering or Computer Science and minimum of 4 years of relevant experience.

Top 3 technical skills that you are required for the role:
Software, Process and Equipment Validation experienceExperience working in Medical Device or other government regulated industries.
Ability to multi-task and handle both project work and day to day activities.

Education Required:
4-year degree in Engineering or Computer ScienceYears'
Experience Required: 4 yearsTime commitment - 40 hours per weekWhat product line will this person support?
  • Production of Capital Equipment.
Production of Accessory Kits that support Capital Equipment. Incoming Inspection. Processing of NCMRs and CAPAs.

This is a mostly on-site role but would be some room to discuss a hybrid role (1-2 days a week at home) depending on current assignments.