Quality Assurance Manager

Real Time CFOs; Davis (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Real Time CFOs, established in California, is seeking a Quality Assurance Manager to oversee compliance with FDA, ISO, and USDA regulations. Responsibilities include managing CAPAs, training programs, and all quality records across the organization.

The ideal candidate will possess a BS in Engineering or equivalent, with over 5 years of experience in compliance within the IVD/medical device sector. Strong leadership and communication skills are essential for effective collaboration across functional areas.

Qualifications

• 5+ years' experience in a compliance role in IVD/medical device companies.
• SixSigma/Lean Manufacturing training and experience highly desirable.
• Demonstrated understanding of establishing an ISO regulated environment.

Responsibilities

• Ensure compliance with applicable regulations (FDA, ISO, USDA).
• Manage CAPA documentation and processes effectively.
• Oversee internal and third-party audit preparations.
• Maintain training programs and quality records.
• Facilitate development of Quality System documents.

Skills

Hands on experience with implementing electronic Quality System(s)

Strong attention to details

Ability to lead and facilitate projects

Collaboration across functional groups

Effective communication skills

Solid analytical problem-solving skills

Dependability and ownership

Adaptability in work environment

Working knowledge of Microsoft Office

Education

BS in Engineering, Chemistry, or relevant scientific discipline

Job description

Job Description

Established manufacturing firm in the biotechnology industry is looking for a Quality Assurance Manager. Cutting edge company with a passion for advancement an innovative team.

This position is responsible for ensuring that Expression Systems Quality System is established and maintained in compliance with applicable regulations (FDA, ISO, USDA, etc.); ensuring CAPAs are well documented and managed effectively to ensure timely closure; performing and managing supplier/partner and internal audit programs; supporting with the facilitation third party audits (including engagement in tasks related to FDA/OSHA/ISO readiness); and managing the Document Control, Complaint Handling, and Training programs.

It is extremely important that the incumbent demonstrates an appropriate level of responsiveness to identified issues. The incumbent must demonstrate timely turnaround time for corrective/preventive actions, DCOs, and other quality system documents and records.

Description: Works with coordinating all data transfer from QA and QC groups into LIMS systems and appropriate GMP level documentation throughout the organization.

Work effectively with CAPA Process Owners to determine root cause(s), formulate suitable corrective and preventive actions, determine appropriate effectiveness checks, and escalating issues to CAPAs if appropriate, and facilitate CAPAs to ensure that they are adequately documented and closed in a timely manner. Hold periodic meeting with CAPA committee, generate reports and metrics, and proactively keep senior RA/QA management abreast of emerging trends.

Support with the development of the Internal Audit Schedules, and ensure in-depth audits are conducted in accordance with approved schedules. Ensure audit reports generated are timely, and responses received are timely and adequate. Verify closure to corrective/preventive actions, and maintain files in current status.

Ensure that Internal audit files are maintained in current status and internal audit findings are closed after appropriate effectiveness checks. Clean up current state of documents and files and digitally convert things as needed. Maintain all current document trails and set up a companywide system moving forward.

Oversee the company's Training Program to ensure that training requirements for all employees are documented.

Provide/Develop GMP Trainings as necessary.

Manage the Complaint Handling function, ensuring that complaints are processed in a uniform and timely manner.

Monitor, trend and analyze results from all sources of corrective/preventive action, and submit for Management Review to Management Representative on a periodic basis. Open CAPAs as necessary.

Write, facilitate the development of, and approve Quality System documents to ensure compliance with applicable regulations, while incorporating industry best practices.

Review, approve and effectively close Deviation Reports.

Ensure compliance with applicable regulatory requirements for Document Control (including documents of external origin). Effectively implement industry best practices for paper and electronic systems.

Maintain all Quality records at Expression Systems in a highly organized manner such that they readily retrievable for reference and review.

Maintain current and in-depth knowledge of FDA/ISO and applicable international policies and regulations that may affect the company's products and customers.

Participate in Quality System improvement initiatives, as assigned.

Qualifications

Additional Skills

• Hands on experience with successfully implementing electronic Quality System(s).
• Strong attention to details.
• Management: Empower and enable staff to perform optimally. Ability to lead and facilitate projects to conclusion.
• Sense of Urgency: Demonstrate appropriate sense of urgency with regards to responsiveness with addressing any high risk compliance issues, and manage compliance risk proactively.
• Collaboration: Be able to work effectively across functional groups and various levels within the organization to achieve positive results.
• Judgment: Exhibit sound and accurate judgment; providing reasoning for decisions.
• Communication: Demonstrate active listening through full attention. Read analyses and reports, interpret technical procedures and government regulations, write reports, business correspondence and procedures. Disseminate knowledge and information on regulations utilizing appropriate media with strong verbal, non-verbal and written skills.
• Planning/Organizing: Prioritize and plan work activities; using time efficiently; plan for additional resources; set goals and objectives; organize and schedule tasks for direct reports and develop realistic action plans. Demonstrate ability to multi-task keeping company objectives and compliance risk in mind.
• Problem Solving: Demonstrate solid analytical skills to define problems, compile data, establish facts, and draw valid conclusions. Identify and resolve problems in a timely manner; uses reason even when dealing with difficult or emotional topics. Must be resourceful.
• Dependability: Take ownership and responsibility for assigned actions. Complete tasks on time to keep commitments, or notify appropriate person(s) with an alternative plan.
• Adaptability: Adapt to changes in the work environment, and demonstrate flexibility.
• Professional Behavior: Treat people with respect, work with integrity and uphold company values. Maintain professional behavior under all circumstances including in very difficult situations.
• Computer: Working knowledge and experience in basic computer programs such as Microsoft Word, PowerPoint, Visio, Excel, Outlook and Microsoft Project, LIMS.

Requirements:

• BS in Engineering, Chemistry, or other relevant scientific discipline or relevant experience.
• SixSigma/Lean Manufacturing training and experience highly desirable.
• Demonstrated understanding of establishing an ISO regulated environment for CLASS II medical Device highly desirable.
• Lead Assessor certification preferred.
• 5 plus years' experience in a compliance role in IVD/medical device companies.