Senior Quality Engineer (QC Team Lead) – Product Quality Assurance

The primary purpose of this role is to provide QA support to our Manufacturing and Distribution teams and direct supervision of the Quality Control team members. The role ensures the QC team operates effectively in supporting the Manufacturing and Distribution teams to meet their KPI of delivering Quality product on time to cost targets.

Let’s talk about Responsibilities

• Quality Assurance: Collaborate with teams to develop and maintain quality standards, procedures, and documentation in compliance with regulatory requirements and manage non-conformance and global on-hold processes across US operations sites.
• Perform data and trend analyses to support organizational needs, non-conformance management and continuous improvement activities.
• Root Cause Analysis: Lead/Support investigations into quality issues, conducting root cause analysis and implementing corrective and preventive actions as necessary.
• Risk Management: Work with global Quality teams to Assess and mitigate quality risks throughout the product lifecycle, including supplier quality management and incoming inspection processes.
• Quality Control Oversight: Direct supervision of QC team members to oversee all aspects of Quality Control operations, ensuring adherence to established protocols and standards.
• Supervision: Supervise QC technicians and inspectors, providing guidance, training, and review and support of team members’ development to ensure accurate and efficient performance.
• Continuous Improvement: Drive a culture of continuous improvement, promoting best practices and collaborating with cross-functional teams to implement initiatives to enhance efficiency and effectiveness.
• Regulatory Compliance: Ensure compliance with relevant regulatory requirements, standards, and guidelines, such as ISO 13485 and FDA regulations.
• Cross-Functional Collaboration: Build collaborative relationships with cross-functional teams, including distribution, servicing, and manufacturing, to support product development, manufacturing, and release processes and ensure adherence to Quality and GMP requirements.
• Data Analysis: Analyze QC data and metrics to monitor performance, identify trends, and implement corrective actions as needed.

Work Environment

• This position works in an operations/warehouse environment.
• While performing the duties of this job, the employee is regularly required to use hands to handle or feel objects, tools or controls.
• The employee frequently is required to walk, stand, and sit and reach with hands and arms.
• The employee is occasionally required to stoop, kneel, crouch and smell.
• The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.
• The employee is occasionally required to lift up to 25 pounds over head.
• Specific vision abilities required by this job include peripheral vision, depth perception, ability to differentiate color and the ability to adjust focus.

Let’s talk about Qualifications and Experience

Required:

• Bachelor’s degree in Engineering or a related field
• 5 years experience in a regulated volume manufacturing industry. 
• Strong understanding of quality control principles and methodologies, including statistical process control (SPC) and quality management systems (QMS).
• Knowledge of relevant regulatory requirements and standards, such as ISO 13485 and FDA regulations.
• Excellent analytical and problem-solving skills, with the ability to conduct root cause analysis and implement effective solutions.
• Strong relationship management and communication skills, with the ability to effectively communicate complex technical information to cross-functional teams.
• Experience with quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and DMAIC, is a plus.

Preferred:

• Advanced degree preferred (Masters in Engineering, Biomedical Engineering, MBA etc.)
• Experience in high volume manufacturing & distribution within medical device or healthcare industry.
• Proven experience in supervising and leading teams

We are shaping the future at ResMed, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, provide flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to our team members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care manag