*Acara Solutions is looking for a Quality Engineer III for one of our medical device manufacturing in Fort Wayne, Indiana*
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Provide work direction for 3-5 Technicians/Inspectors.
*Responsibilities:*
Adheres to Core Beliefs and all safety and quality requirements including, but not limited to:
* Quality Management Systems (QMS), Environmental Management Systems (EMS), U.
S.
Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
* Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
* Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
* Leads and implements various product and process improvement methodologies.
* Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
* Leads in the completion and maintenance of risk analysis.
* Leads generation and completion of protocols and reports for test method validations.
* Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
Recommends process monitoring devices where applicable.
* Develops various inspection techniques and procedures to ensure product integrity to design specifications.
Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
* Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
* Effectively communicate and interact with customers.
* Leads and manage complaint investigations.
* Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
* Assists with product transfers.
* Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems.
Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
* Coordinates and leads the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions.
* Provides support to other quality engineers.
* Performs other functions as required.
* Manage a heavy workload while maintaining accuracy.
* Identify potential roadblocks and provide innovative solutions.
* Operate with a high level of integrity and professionalism.
* Committed to and accountable for achieving goals and objectives.
*Education/Certification*
* Bachelor's Degree in Engineering or related field required or 7-10 years of experience working in a quality engineering role within a regulated industry.
*Experience*
* 5-7 years' experience in medical device or regulated manufacturing
Job Types: Full-time, Permanent
Salary: Up to $110,000.
00 per year
Benefits:
* 401(k)
* 401(k) matching
* Dental insurance
* Health insurance
* Life insurance
* Paid time off
* Vision insurance
Schedule:
* 8 hour shift
Work setting:
* In-person
Education:
* Bachelor's (Preferred)
Experience:
* Medical device or regulated manufacturing: 1 year (Preferred)
* Quality Engineer: 1 year (Preferred)
Work Location: In person
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