Specialist, Quality (Quality Systems) - #1164618

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an impact:
• Ensure compliance (including acting as the co-owner) of quality system processes (e.g., Training, internal auditing, Quality planning, etc.) Including optimizing quality systems processes using engineering methods
• Drive routine regulatory compliance related activities i.e ECR review with RA counterpart, Tier meeting
• Identify, co-lead and implement business process improvement solutions for Quality Systems, including developing changes to procedures, to improve operation, efficiencies, and user experience, while supporting the integrity of the business process
• Execute internal audit considering scope to ensure an efficient and effective audit program
• Assess previous audit findings to establish priorities and strategies
• Identify continuous improvement opportunities including performing analysis and may present metrics to all level of the organization
• Facilitate management and peers to assess and improve the adequacy of the processes, which includes but is not limited to the remediation of Quality System deficiencies noted in audits and/or inspections
• Other incidental duties

What you'll need (Required):
• Bachelor's Degree in in Scientific/Engineering field, minimum 3 years of experience in Quality Systems or Quality related roles required
• Other: experience in medical device or pharmaceutical industry preferred

What else we look for (Preferred):
• Strong knowledge on ISO 13485
• Good understanding of US Quality Systems Regulation (21 CFR Part 820), JPAL, CMDR and other applicable regulations. Strong knowledge on DMAIC Approach and experience in Six Sigma Methodologies / Continuous Improvements Methodologies.
• Excellent written and verbal English communication skills including negotiating, relationship management and presentation skills
• Good computer skills in usage of MS Office Suite and ability to operate general office machinery
• Basic understanding of statistical techniques
• Good problem-solving and critical thinking skills
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control