Performs audits, inspections, configuration checks, and functional testing of in-process materials, parts and subassemblies used in the manufacture of partially assembled or finished medical devices. Responsible for assuring that the company's products have been manufactured, inspected and tested using company approved procedures documents and equipment. Work with R&D, Manufacturing, and Quality to implement solutions to quality related problems. Coordinates, initiates, and implements Document Change Orders. Reviews quality records to ensure completeness and compliance to applicable quality procedures.
Responsibilities
Perform wide variety of audits, inspections, configuration checks, and functional testing to ensure quality of manufactured goods and adherence to quality procedures.
Assist in design verification/validation, equipment qualification, and process validation studies.
Check lot history records for completeness, accuracy, and conformance to SOP. Investigate lot history records related to customer experience reports.
Review test methods, manufacturing and quality instructions, and inspection procedures for correctness.
Conduct and document good manufacturing practice audits.
Monitor calibration and maintenance of all test equipment and fixtures and operation of equipment.
Write and update procedures and checklists within MasterControl and perform data entry tasks as assigned.
Take actions to ensure that nonconforming practices and procedures are corrected.
Evaluate problems and make initial recommendations for possible corrective action to supervisor.
Perform physical testing of components, subassemblies and finished devices to help ensure quality of manufactured products.
Perform other duties as assigned by supervisor
Position will require you to be working onsite at 100% and requires proof that the applicant is fully vaccinated against COVID-19, subject to applicable law
Qualifications
Good verbal and written communication and interpersonal skills.
General proficiency in basic computer skills, including MS Office software suite (Outlook, Excel, Word, Access and Power Point).
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Detail oriented with focus on compliance to both internal and external requirements and understanding of good manufacturing practices.
Normally receives no instructions on routine work, general instructions on new assignments.
Education:
High school diploma or general education degree (GED); or equivalent combination of education and experience.
Experience:
Entry-level position, manufacturing or laboratory experience in a related industry or Medical device preferred.
Proof of current, complete covid vaccination is a requirement for employment with Endologix LLC
