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Quality Systems Compliance Engineer

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 Quality Systems Compliance Engineer who is:
Driven and focused on ensuring quality for all manufacturing with a focus on CAPA activities to support the quality system and ISO 13485.
Assists with the analysis, oversight, and verification of the Quality Systems and maintaining compliance to all applicable regulatory requirements.
Self-motivated and thrives in a fast paced, team-driven, lean systems environment, where every day brings new projects and challenges.
Basic Responsibilities
Maintain Quality System documentation and ensure that the most current revisions of federal and international standards are in place at all times. Obtain new standards to support the Quality System as they are made available by federal and international regulatory agencies.
Serve as Deputy Management Representative, reporting to top management on the performance of the implementation of quality management system and any need for improvement.
Gather data and prepare reports for management review activities.
Complaint resolution including containment, root cause analysis, corrective action, preventative action and mistake proofing implementation.
Initiate investigations of product complaints upon receipt of complaint information from customer.
Perform and document technical evaluations of returned product.
Communicate complaint findings to the entire organization as well as customers.
Manage the CAPA program and create monthly CAPA reports.
Manage and execute the Internal Audit program.
Participate in external quality audits as required.
Assists management teams to ensure timely closure of audit observations.
Assess proposed suppliers quality systems for eligibility as an approved Helix supplier and conduct reassessment of existing suppliers within the required timeframes.
Coordinate the resolution of supplier quality issues.
Tracks deviations in operating procedures and policies through established mechanism. Reports errors, deficiencies, discrepancies and observations to management.
Provide document change order support.
Participate and support in safety and lean/continuous improvement initiatives.
Required Qualifications
Bachelor of Science degree in Engineering Chemistry, Biology or related field
3 to 5 years related experience and/or training and working knowledge of 21CFR820 and ISO 13485 standard.
Experience in performing internal audits.
Experience in performing supplier assessments.
CAPA experience to include review for risk analysis, correction, preventative action and closure of CAPA issues.
Experience in a metric driven culture.
Understand and working knowledge of statistical techniques (i.e. samples size determination, DOE, Lean and Six Sigma process improvement techniques, etc.)
Knowledge and understanding of quality requirements for the medical device industry with general technical understanding of business operations.
Demonstrated knowledge in Quality System Regulations/Good Manufacturing Practices.
Understanding & working knowledge of Risk Assessment techniques and tools (i.e. FMEA).
Able to read and comprehend federal and international (English Language Version) regulatory standards and guidelines.
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
Able to organize data and information into clear, concise, and legible report format.
Strong critical thinking and problem solving tools.
Ability to communicate effectively (written & spoken) as required for job related communication throughout the organization.
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
Ability to work in excess of a 40-hour week if necessary with ability to travel on occasion.
Flexibility to work different shifts as needed.
Preferred Qualifications:
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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