medmix
Senior Quality Engineer - Medical Devices
medmix - Flowery Branch, Georgia, United States, 30542
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Overview
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Overview
Senior Quality Engineer - Medical Devices
medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2,600 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). The Senior Quality Engineer is responsible for supporting the Healthcare business by developing and executing engineering and validation strategies, plans, and protocols to include facility, equipment, process and software. Job Description
Provide Quality oversight to ensure quality processes are in place for the qualification of lab equipment and fixtures prior to use for GxP activity Responsible to ensure device testing, method development, method transfers and troubleshooting and all related documentation is compliant to applicable regulations Identify and control Manufacturing process defects (scrap, nonconforming material, custom complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions Support plans for development, verification/validation, technology transfer and risk management in line with applicable regulations for medical device products Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, and Transfer Plans Support root cause investigations, provide compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectations Draft, reviews, and approves Quality Agreements (QAG) for equipment vendor, method developers, and service providers Qualifications
Successfully accomplished Bachelor of Science degree in an engineering field Long-term validation experience in a regulated manufacturing environment (FDA, EU) related to quality control of medical devices per ISO 13485 and 21 CFR 820 Mastery of SOPs and other compliance requirements and regulatory guidelines as well as good documentation practices and cGMP standards Experience working in a clean room environment and performing process and equipment validations Thorough understanding of ISO 14971 from implementation through device lifecycle Experience with injection molding processes, parameters, and troubleshooting is preferred Fluent English communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization Additional Information
Benefits we offer: Up to three (3) weeks of paid time off beginning your first year Twelve (12) company paid holidays per year Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability, Identity Theft and Legal Protection plan options medmix Employee Savings Plan / 401k with 100% employer match up to 6% of your annual base salary Eligible to receive additional non-elective 401k contributions on a quarterly basis Health Savings Account with dollar-for-dollar matching based on coverage level Flexible working hours Employee Assistance, Health and Wellness Program An innovative, vibrant and agile culture Growth opportunities in a globally successful and dynamic business on a growth trajectory Access to a wide range of discounts on shopping, entertainment and lifestyle medmix is an equal opportunity employer, committed to the strength of a diverse workforce. 93% of our employees would go above and beyond to deliver results
do you have the drive to succeed? Join us and boost your career, starting today! All information will be kept confidential according to EEO guidelines.
medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer, and industrial end-markets. Our customers benefit from our dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 14 production sites worldwide, together with our highly motivated and experienced team of nearly 2,600 employees provide our customers with uncompromising quality, proximity, and agility. medmix is headquartered in Baar, Switzerland. Our shares are traded on the SIX Swiss Exchange (SIX: MEDX). The Senior Quality Engineer is responsible for supporting the Healthcare business by developing and executing engineering and validation strategies, plans, and protocols to include facility, equipment, process and software. Job Description
Provide Quality oversight to ensure quality processes are in place for the qualification of lab equipment and fixtures prior to use for GxP activity Responsible to ensure device testing, method development, method transfers and troubleshooting and all related documentation is compliant to applicable regulations Identify and control Manufacturing process defects (scrap, nonconforming material, custom complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions Support plans for development, verification/validation, technology transfer and risk management in line with applicable regulations for medical device products Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, and Transfer Plans Support root cause investigations, provide compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectations Draft, reviews, and approves Quality Agreements (QAG) for equipment vendor, method developers, and service providers Qualifications
Successfully accomplished Bachelor of Science degree in an engineering field Long-term validation experience in a regulated manufacturing environment (FDA, EU) related to quality control of medical devices per ISO 13485 and 21 CFR 820 Mastery of SOPs and other compliance requirements and regulatory guidelines as well as good documentation practices and cGMP standards Experience working in a clean room environment and performing process and equipment validations Thorough understanding of ISO 14971 from implementation through device lifecycle Experience with injection molding processes, parameters, and troubleshooting is preferred Fluent English communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization Additional Information
Benefits we offer: Up to three (3) weeks of paid time off beginning your first year Twelve (12) company paid holidays per year Medical, dental, vision, Life/AD&D, Short- and Long-Term Disability, Identity Theft and Legal Protection plan options medmix Employee Savings Plan / 401k with 100% employer match up to 6% of your annual base salary Eligible to receive additional non-elective 401k contributions on a quarterly basis Health Savings Account with dollar-for-dollar matching based on coverage level Flexible working hours Employee Assistance, Health and Wellness Program An innovative, vibrant and agile culture Growth opportunities in a globally successful and dynamic business on a growth trajectory Access to a wide range of discounts on shopping, entertainment and lifestyle medmix is an equal opportunity employer, committed to the strength of a diverse workforce. 93% of our employees would go above and beyond to deliver results
do you have the drive to succeed? Join us and boost your career, starting today! All information will be kept confidential according to EEO guidelines.