Manager, Engineering - Quality

Manager, Engineering - Quality - ( 24300542 )

Description

Responsibilities:

Provide effective tactical Quality leadership for Quality Engineers. Interact and communicate with Senior Leadership across ICU Medical regarding program status, risks, mitigation plans and business objectives. Effectively deploy and assure compliance with ICU Medical’s Quality System such as Design Controls, risk analysis/management tools, design validation, design verification, investigations, CA/PA data, etc. to assure product quality. Support manufacturing site inspections/audits, representing and defending Design Control compliance for medical device products. Assure systems conform to all applicable US and international regulatory requirements and coordinate development of data and responses for regulators. Understand medical device regulations and assure ICU Medical Quality Systems and documentation remain compliant. Ensure all Quality attributes for design changes and fixes are met. Work with cross-functional teams to coordinate product changes. Provide corporate quality support, guidance and direction for all manufacturing facilities including driving/managing on-market product issues to closure and escalating to senior management for support as necessary. Define, evaluate, prioritize and correct potential product and process risks to drive continuous quality improvements. Represent the Quality organization as the core team member on Platform/Business teams. Work with on-market teams regarding product life-cycle management and change management.
*Hybrid work is permissible. When not working from home, must report to San Clemente, CA office. *International and domestic travel required up to 20% of the year.

EDUCATION AND EXPERIENCE REQUIREMENTS:

Bachelor’s degree (or foreign equivalent) in Mechanical Engineering, Bio Engineering, Materials Science, Physics, Electronics Engineering or closely related plus Eight (8) years of experience in the job offered or a closely related occupation.

SPECIAL REQUIREMENTS:

Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be “quantified” by “time.” Required expertise/knowledge includes: Experience in overseeing a risk management system that is compliant to ISO 14971 including, but not limited to, compiling risk management files, creating design failure mode and effect analysis, and developing product hazard analyses in support of both new product development and design changes to commercially available medical devices; Proven track record of supporting the design and development of new products including the necessary design quality evidence to receive global regulatory clearances; Proficient in various quality engineering and continuous improvement tools including, but not limited to, statistical analysis for acceptance of new product designs and development and validation of test methods for product design acceptance testing; Proficient in root cause analysis techniques to investigate product design issues, e.g. design of experiments (DOE); Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.); Systems level product development experience with an appreciation for interactions of components, materials, drugs and manufacturing processes; Experience managing quality engineers and working cross functionally with R&D.

JOB LOCATION: ICU Medical, Inc., 951 Calle Amanecer, San Clemente, CA 92673

40 hours per week / $146,973 - $147,973 per year

ICU Medical, Inc. is an equal opportunity employer.

To apply for ICU Medical’s Manager, Quality Engineering – Consumables position please send resume to:

Must reference JOB CODE: CA1019DP

EOE M/F/D/V

It is the policy of ICU Medical, Inc. to afford full equal employment opportunity to qualified employees and applicants, regardless of their race, color, religion, sex, national origin, age, physical or mental handicaps, military or veteran status, sexual preference, or any other protected condition or characteristic in conformity with all applicable federal, state and local laws and regulations.

Primary Location: US-CA-San Clemente

Schedule: Full-time

Shift: Day Job