Sr Quality Systems Engineer - ISO 13485
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 Systems Engineer who is:
o Responsible for managing cross functional involvement for CAPA, internal/external audits and document control.
o Hands-on with a detailed mind-set to transfer (ISO13485 and 21CFR820) into a cost-conscious and effective quality system
o A big picture thinker who can execute project tasks within a scope of work to defined deadlines.
o Self-motivated and thrives in a fast -paced, cutting-edge, lean systems environment, where priorities can often change on a daily basis.
Basic Responsibilities
o 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.
o Manage the CAPA program and CAPA Review Board as well as the Change Control Board.
o Manage and execute the Internal Audit program.
o Serve as Deputy Management Representative, reporting to top management on the performance of the implementation of quality management system and any need for improvement.
o Gather data and prepare reports for management review activities.
o Complaint resolution including containment, root cause analysis, corrective action, preventative action and mistake proofing implementation.
o Provides technical guidance on complex problems, but independently determines and develops approaches and solutions.
o Shares technical expertise with others and helps develop junior level engineers.
o Develops and establishes effective quality control and risk management activities.
o Writes reviews and/or approves process and product validation protocols and reports, equipment qualifications, engineering reports and change orders.
o Uses statistical tools (Minitab, etc) to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
o Assists management teams to ensure timely closure of audit observations.
o Assess proposed suppliers' quality systems for eligibility as an approved Helix supplier and conduct reassessment of existing suppliers within the required timeframes.
o Coordinate the resolution of supplier quality issues.
o Tracks deviations in operating procedures and policies through established mechanism. Reports errors, deficiencies, discrepancies and observations to management.
o Leads the document control process.
o Identify and implement opportunities for continuous improvement.
Required Qualifications
o Bachelor's Degree in Engineering, Chemistry, Biology or related field.
o 5
years related quality systems engineering experience and/or training and working knowledge of 21CFR820 and ISO 13485 standard.
o Experience in performing internal and external audits.
o Experience in performing supplier assessments.
o CAPA experience to include review for risk analysis, correction, preventative action and closure of CAPA issues.
o Experience in a metric driven culture.
o Understand and working knowledge of statistical techniques (i.e. samples size determination, DOE, Lean and Six Sigma process improvement techniques, etc.)
o Knowledge and understanding of quality requirements for the medical device industry with general technical understanding of business operations.
o Understanding & working knowledge of Risk Assessment techniques and tools (i.e. FMEA).
o Proficient in Microsoft Office Suite.
o Able to read and comprehend federal and international (English Language Version) regulatory standards and guidelines.
o Strong verbal, written and interpersonal skills to effectively work in a team environment; high customer empathy and desire to enthusiastically serve.
o Able to organize data and information into clear, concise, and legible report format.
o Strong critical thinking and problem solving tools.
o Ability to communicate effectively (written & spoken) as required for job related communication throughout the organization.
o Ability to work in excess of a 40-hour work week as necessary.
o Flexibility to work different shifts as needed.
o Regular attendance required.
o Travel as required (minimal).
It's 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 www.helixmedical.com/careers.
To Apply:
Candidates meeting these qualifications should complete the online application: https://freudenberg-jobs.dvinci.de/cgi-bin/appl/selfservice.pl?action=startapp;job_pub_nr=3528DC98-8ED7-4013-980F-8C82649218BE;p=homepage_com;job_pub_type=extern
Helix Medical is an Equal Employment Opportunity Employer.Estimated Salary: $20 to $28 per hour based on qualifications.
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 Systems Engineer who is:
o Responsible for managing cross functional involvement for CAPA, internal/external audits and document control.
o Hands-on with a detailed mind-set to transfer (ISO13485 and 21CFR820) into a cost-conscious and effective quality system
o A big picture thinker who can execute project tasks within a scope of work to defined deadlines.
o Self-motivated and thrives in a fast -paced, cutting-edge, lean systems environment, where priorities can often change on a daily basis.
Basic Responsibilities
o 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.
o Manage the CAPA program and CAPA Review Board as well as the Change Control Board.
o Manage and execute the Internal Audit program.
o Serve as Deputy Management Representative, reporting to top management on the performance of the implementation of quality management system and any need for improvement.
o Gather data and prepare reports for management review activities.
o Complaint resolution including containment, root cause analysis, corrective action, preventative action and mistake proofing implementation.
o Provides technical guidance on complex problems, but independently determines and develops approaches and solutions.
o Shares technical expertise with others and helps develop junior level engineers.
o Develops and establishes effective quality control and risk management activities.
o Writes reviews and/or approves process and product validation protocols and reports, equipment qualifications, engineering reports and change orders.
o Uses statistical tools (Minitab, etc) to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
o Assists management teams to ensure timely closure of audit observations.
o Assess proposed suppliers' quality systems for eligibility as an approved Helix supplier and conduct reassessment of existing suppliers within the required timeframes.
o Coordinate the resolution of supplier quality issues.
o Tracks deviations in operating procedures and policies through established mechanism. Reports errors, deficiencies, discrepancies and observations to management.
o Leads the document control process.
o Identify and implement opportunities for continuous improvement.
Required Qualifications
o Bachelor's Degree in Engineering, Chemistry, Biology or related field.
o 5
years related quality systems engineering experience and/or training and working knowledge of 21CFR820 and ISO 13485 standard.
o Experience in performing internal and external audits.
o Experience in performing supplier assessments.
o CAPA experience to include review for risk analysis, correction, preventative action and closure of CAPA issues.
o Experience in a metric driven culture.
o Understand and working knowledge of statistical techniques (i.e. samples size determination, DOE, Lean and Six Sigma process improvement techniques, etc.)
o Knowledge and understanding of quality requirements for the medical device industry with general technical understanding of business operations.
o Understanding & working knowledge of Risk Assessment techniques and tools (i.e. FMEA).
o Proficient in Microsoft Office Suite.
o Able to read and comprehend federal and international (English Language Version) regulatory standards and guidelines.
o Strong verbal, written and interpersonal skills to effectively work in a team environment; high customer empathy and desire to enthusiastically serve.
o Able to organize data and information into clear, concise, and legible report format.
o Strong critical thinking and problem solving tools.
o Ability to communicate effectively (written & spoken) as required for job related communication throughout the organization.
o Ability to work in excess of a 40-hour work week as necessary.
o Flexibility to work different shifts as needed.
o Regular attendance required.
o Travel as required (minimal).
It's 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 www.helixmedical.com/careers.
To Apply:
Candidates meeting these qualifications should complete the online application: https://freudenberg-jobs.dvinci.de/cgi-bin/appl/selfservice.pl?action=startapp;job_pub_nr=3528DC98-8ED7-4013-980F-8C82649218BE;p=homepage_com;job_pub_type=extern
Helix Medical is an Equal Employment Opportunity Employer.Estimated Salary: $20 to $28 per hour based on qualifications.
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