TeraPore Technologies is a venture-backed startup developing cutting edge nano-separations materials for the biopharmaceutical market and beyond. Our team is comprised of scientists, engineers, separation experts, and biopharma industry veterans, all passionate about enabling safer, cleaner life science products.
TeraPore is seeking a Quality Systems Manager responsible for developing the Quality strategy, policies, processes, standards and systems for the Company and its supply chains. This individual will develop and sustain the Quality Management System (QMS) in line with the required industry standards (including: ISO 13485 / ISO 9001), and business requirements across the organization through existing and new procedures. The Quality Systems Manager will regulate, control and improve the quality of all processes throughout the business, manage the audit program to ensure that all nonconformities raised against certification bodies during audits are effectively corrected and embed a culture of continuous improvement throughout the company.
This role reports to the VP of Operations and is based out of our South San Francisco office.
- Develop, implement, and maintain the Quality Management System (QMS), manage documentation under revision control including SOPs, design control documentation, measurement methods, tests and products records.
- Contribute to new business initiatives and projects and review and communicate the impact on Quality Management Systems.
- Manage all external registration requirements to ensure they are met.
- Ensure that all in-house systems and procedures are updated, revised and modified to meet the needs of external certification bodies.
- Update quality documentation and communicate lessons learned from quality concerns.
- Train others in all aspects of the Quality System and application of procedures.
- Undertake regular internal QMS audits.
- Ensure corrective actions are undertaken to address non conformities found. Manage the nonconformity data base and provide detailed analysis of nonconformities. Supervise and manage the Corrective Action Preventative Action program.
- Ensure ongoing compliance with the Quality Management System (ISO9001).
- Develop, implement, and manage key performance indicators (KPIs) across the organization.
- Review, implement and update company records e.g. training matrices, performance reviews, risk assessments.
- Work as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities to optimize results and improve quality in line with the Company’s quality standards requirements.
Qualifications and Skills:
- BS or higher degree in Science or Engineering field.
- 5+ years of experience in high tech manufacturing environment.
- Proven record of Quality Manager.
- Knowledge ISO 13485 and GPM requirements is a plus.
- Outstanding communication, written, verbal and presentation skills.
- Excellent organizational and leadership skills.
- Proficient in MS Office and knowledge of data analysis.
- In depth understanding of quality control procedures and relevant legal standards.
- Certification as Internal Auditor is a strong advantage (ISO 9001).
- Develop/ implement processes and procedures for cross-functional workflows to secure compliance to all regulatory requirements.
- Lead and oversee internal audit team.
- Administer and manage the supplier quality program.
- Perform risk management activities at all phases of device life cycle.
- Knowledge and/or professional certification related to the field of Six Sigma/Lean Manufacturing, GMP is a plus.
- Analytical decision-making and problem-solving skills are essential.
This job is ideal for someone who is:
- A self-starter, motivated and able to positively motivate others.
- Focused, target driven with a positive, can-do attitude skills and attributes.
- With excellent leadership, man- management, and interpersonal skills.