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

Job purpose 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. Main Accountabilities and tasks 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. Identifies and controls 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. Actively participates in test method development, and transfer meetings to other labs representing the quality assurance function to ensure compliance with procedures. Support the development of 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. Supports root cause investigations, provides compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectations. Reviews and approves complaint investigation and root cause, CAPAs. Analyze, trend, and report data supporting the quality system. Draft, reviews, and approves Quality Agreements (QAG) for equipment vendor, method developers, and service providers. Other duties as assigned. Qualifications

Desired experience and qualifications Work Experience : 7+ years of validation experience in a regulated manufacturing environment related to quality control of medical devices per ISO 13485 and 21 CFR 820. Education : BS degree in engineering field Other: Experience with injection molding processes, parameters, and troubleshooting is preferred. Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment. Required experience with good documentation practices and cGMP standards. Thorough understanding of ISO 14971 from implementation through device lifecycle. Proficiency in the use of personal computers, especially word processing software, spreadsheets, presentation, and database software. Experience working in a clean room environment and performing process and equipment validations. Ability to perform work accurately and thoroughly and to work independently with minimal supervision. Must be organized and able to follow a systematic method of performing tasks and the ability to organize and direct a project to completion. Must be self-directed and motivated to optimally utilize the available time to organize and complete expected work within given deadlines and reasonable work schedules. Communication skills, both oral and written, as required to communicate effectively with others at all levels in the organization and to provide clear and concise reports and policies as needed. Ability to effectively present information publicly. Ability to work well with subordinates, peers and superiors in all departments.

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.