Company Description

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). www.medmix.swiss

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

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