Quality Systems Coordinator I/II

Location: Rancho Santa Margarita, California, United States

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

The Quality Systems Coordinator I or II supports Applied Medical's quality system by maintaining standards, guidances, and regulations, supporting the learning management system, and facilitating updates to standard operating procedures (SOPs). This position is available at the Quality Systems Coordinator I or Quality Systems Coordinator II levels, with placement determined by experience. The Quality Systems Coordinator plays a hands on role in maintenance of quality documentation, training, and external requirement management.

Key Responsibilities

• Maintains standards, guidances, and regulations and manages the associated change control process.
• Monitors for and identifies changes in external regulatory requirements.
• Processes submitted requests for edits within the learning management system.
• Performs administrative tasks to support updates to standard operating procedures, organizing meetings and standardizing formatting for proposed changes.
• Supports external audits by retrieving and organizing requested documentation.
• Collaborates with cross-functional teams and departments to accomplish quality system tasks.

Success in This Role Looks Like

• Keeps standards, guidances, and regulations current and accurately tracked.
• Identifies external regulatory changes
• Supports smooth, well-organized updates to standard operating procedures.
• Builds strong working relationships across departments and functions.

This Position Requires the Following Skills and Attributes

• Holds an associate's degree or above in a technical discipline prefered, or brings equivalent technical expertise.
• Works independently and collaborates effectively with departmental and cross-functional team members.
• Demonstrates strong analytical skills and meticulous attention to detail.
• Raises and escalates issues appropriately.
• Communicates clearly in written and verbal formats, including presentations.
• Works with internal and external customers in a service oriented manner.

The Following Skills and Attributes Are Preferred

• Brings technical writing experience.
• Demonstrates familiarity with medical device standards, guidances, and regulations.

• Competitive compensation range: $24 - $32 / hour (California). 
• Comprehensive benefits package. 
• Training and mentorship opportunities. 
• On-campus wellness activities. 
• Education reimbursement program. 
• 401(k) program with discretionary employer match. 
• Generous vacation accrual and paid holiday schedule. 

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply. 

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. 

All compensation and benefits are subject to plan documents and written agreements. 

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.

Responsibilities

The Quality Systems Coordinator I or II supports Applied Medical's quality system by maintaining standards, guidances, and regulations, supporting the learning management system, and facilitating updates to standard operating procedures (SOPs). This position is available at the Quality Systems Coordinator I or Quality Systems Coordinator II levels, with placement determined by experience. The Quality Systems Coordinator plays a hands on role in maintenance of quality documentation, training, and external requirement management.

Key Responsibilities

• Maintains standards, guidances, and regulations and manages the associated change control process.
• Monitors for and identifies changes in external regulatory requirements.
• Processes submitted requests for edits within the learning management system.
• Performs administrative tasks to support updates to standard operating procedures, organizing meetings and standardizing formatting for proposed changes.
• Supports external audits by retrieving and organizing requested documentation.
• Collaborates with cross-functional teams and departments to accomplish quality system tasks.

Success in This Role Looks Like

• Keeps standards, guidances, and regulations current and accurately tracked.
• Identifies external regulatory changes
• Supports smooth, well-organized updates to standard operating procedures.
• Builds strong working relationships across departments and functions.

Qualifications

This Position Requires the Following Skills and Attributes

• Holds an associate's degree or above in a technical discipline prefered, or brings equivalent technical expertise.
• Works independently and collaborates effectively with departmental and cross-functional team members.
• Demonstrates strong analytical skills and meticulous attention to detail.
• Raises and escalates issues appropriately.
• Communicates clearly in written and verbal formats, including presentations.
• Works with internal and external customers in a service oriented manner.