Job purpose

The Quality Control lead at True Diagnostics will be responsible for leading the QC team while also ensuring in-process and final released products meets require specifications and requirements.

Duties and responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

• Leads the quality control inspection group for all campaigns ensuring that in process and final released materials conform to specifications and requirements.
• Initiates and collaborates with other groups for Non-Conforming Material Reports (NCMRs) timely closure and coordinating the required action to resolve discrepancies, including coordinating appropriate approvals on NCMRs prior to closure and physical material disposition.
• Trains QC inspectors on NCMR processing and product qualification (inspection and testing) procedures and interfaces with regulatory bodies, third party auditors and other auditors during external and internal audits.
• Assists QC management with employees during performance assessment and with time management.
• Ensures appropriate line clearance is performed at the start and end of each lot/batch.
• Administers the non-conforming material system through processing NCMRs physical segregation and labeling material, transacting in the operating system, and filing of associated quality records per True Diagnostics/ISO/Quality System Regulation (QSR) requirements.
• Ensures daily integrity and congruency of all quarantined material between physical, system and documented records.
• Performs record maintenance for Quality Department records, issuing reports/measures and improvement activities, implements and suggests process improvements.
• Reviews documents, such as batch records, drawings, procedures, work instructions, and forms to verify compliance with document and SOP policies.

Qualifications

• High School diploma or equivalent required.
• Minimum of 5 years' experience in QC related activities in a medical device and/or high-volume manufacturing environment required.
• Strong knowledge of quality systems and regulations for the medical device industry required.
• Ability to work independently and have a deep understanding of the theory and the biology behind the application and the products.
• Extensive knowledge of QC systems and non-conforming material handling requirements required.
• Computer skills, including word processing, excel data manipulation, ERP system, and email required.
• Strong leadership, communication, and people skills required.
• Good oral and written communication skills.
• Ability to effectively interact with employees at all levels of the organization.
• Excellent organization, communication, and critical thinking skills.
• Solid understanding of quality concepts including variation, process control and root cause analysis.
• Excellent documentation and communication skills.

Working conditions

Works in a manufacturing room, typically within a Dry Room. The Dry room is an indoor environment that has controlled temperature and humidity conditions. Required to wear personal protective equipment (PPE) when working in manufacturing room locations.

May be exposed to loud or distracting sounds or noise levels. The position may be required to travel between True Diagnostics buildings locally.

Physical requirements

Physical demands require sitting for extended periods of time, walking, bending, reaching,

carrying, and occasionally lifting and/or moving objects up to 30 pounds.

Job Type: Full-time

Pay: $20.00 - $24.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• 8 hour shift
• Monday to Friday
• Weekends as needed

Work setting:

• In-person

Ability to Commute:

• Carlsbad, CA 92008 (Required)

Work Location: In person