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Sr. Quality Engineer FDA & SPC

Company Name:
Helix Medical
Helix Medical is making a world of difference... all around the world.
As a global leader in medical contract manufacturing we offer the following services for medical device, pharmaceutical and IVD clients worldwide: product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.
For nearly 30 years, medical device and healthcare companies around the world have looked to Helix Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms. Helix Medical maintains design and manufacturing centers in California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland, and China.
We are currently hiring for a Sr Quality Engineer who is:
Driven and focused on ensuring quality for all manufacturing cells in operations and New Business Activities
Striving to utilize statistical process controls to ensure a proactive ability to implement quality improvements
Able to demonstrate a sense of urgency and initiative on the manufacturing floor
Self-motivated and thrives in a fast paced, cutting-edge, lean systems environment, where priorities can often change on a daily basis.
Basic Responsibilities
Supports new product development and product maintenance through the application of quality engineering disciplines and the use of the site quality system and quality system regulations for medical devices.
Provides expertise in statistical analysis for Quality Engineering projects
Supports plant activities in process validation, process capability improvement, and resolving customer issues by initiating corrective and preventive action, with an eye to increased capability and customer satisfaction that support the site Quality System.
Works continuous improvement projects from beginning to end. Characterizes the problem, identifies key process inputs, determines optimal operating window, implements controls to maintain output at desired level, and quantifies the improvement in savings, avoidance, or value.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results Internal and external contacts often pertain to company plans and objectives.
Champions site quality initiatives and participates in the development of site quality plan.
Leads and mentors cross-functional quality engineering project initiatives.
Handles multiple projects and tasks, from product inception through product launch and maintenance.
Plays an active role in the processes to ensure products meet quality standards and are consistent with the site quality system.
Helps establish manufacturing inspection, sampling and statistical process control methods, and procedures to assure quality of manufactured products.
Assures compliance to in-house and external specifications and standards.
Identifies and highlights quality issues by providing input to drive corrective actions to problems identified.
Performs / leads root cause analysis to determine corrective action(s), as necessary.
Interfaces with manufacturing in identifying and correcting quality issues for new and existing product lines.
Assists with the investigation of root cause and determination of corrective and preventive actions relating to NCMRs, CARs, and QANs. Responsible for corrective action effectiveness verification after implementation of corrective actions.
Works with Quality Assurance Manager in providing back-up supervision of Quality Specialists and Quality Leads.
Determines methods and procedures on new assignments, and may provide guidance to other associates.
Required Qualifications
Bachelor of Science degree in Engineering or related field
5+ years quality engineering experience which must be in the medical device industry with FDA experience
Demonstrated competency in statistical process controls including control charts, data analysis, technical writing, continuous process improvement, including lean, six sigma, and validations.
Passion for manufacturing with an on-floor presence to advance product quality standards
Proficient with reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, smart scope, multi-meters, manometers, pull test and other inspection equipment.
Certification in Quality Engineering, Biomedical Auditing, or equivalent
Demonstrated knowledge in Quality System Regulations/Good Manufacturing Practices.
Detail orientated, organizational skills and the ability to handle multiple projects.
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc along with Minitab and Microsoft Project
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
Flexibility to work different shifts as needed.
Ability to travel as required (minimal).
Preferred Qualifications:
Experience and knowledge with injection molding manufacturing operations.
Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and/or Regulatory Assurance Certification (RAC)
Lean/Six Sigma certification
Its an exciting time to work at Helix Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Helix Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more at .
To Apply:
Candidates meeting these qualifications should complete the online application:
Helix Medical is an Equal Employment Opportunity Employer.

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