Quality and PLM System Manager is responsible for overseeing the Product Lifecycle Management (PLM) system, managing Bill of Materials (BOMs), administering change orders, and ensuring effective disposition of materials. In addition will be supporting all Quality Management System activities. The successful candidate will play a crucial role in maintaining compliance with regulatory requirements, optimizing product development processes, and facilitating cross-functional collaboration.
As part of our team, your core responsibilities will be:
- Author, assist in creation, modification, and review all documents used within the Quality System.
- Manage and provide oversite of various Quality System processes such as Document Control, Change Control, Complaint Handling, Internal Audits, Supplier Qualification, Training, CAPA, NCR and etc.
- Define, develop, and maintain various software components and processes utilized in The Quality Management System.
- Own, set up, manage PLM System, includes creation of qualification package (URS, MVP, SOPs and WI)
- Administer and maintain the PLM system, including user access, configurations, and data integrity. Customize workflows, attributes, and templates to support the specific needs of the medical device product development lifecycle. Provide user training and support to ensure effective utilization of the PLM system across departments.
- Manage the creation, maintenance, and revision of Product BOMs throughout the product lifecycle.
- Manage the change control process for product changes, including change initiation and implementation.
- Coordinate with supply chain, operations and engineering dispositioning of the materials affected by product changes, including obsolete components, excess inventory, materials on order and non-conforming materials.
- Ensure accuracy and completeness of BOMs, including component specifications, part numbers, and sourcing information.
- Coordinate with cross-functional teams (engineering, manufacturing, quality) to validate BOMs and resolve discrepancies.
- Work with external stakeholders to implement ERP and PLM linkage.
- Assist with Document Change Orders and eQMS set up.
- Assist in NCMR, CAPA, Deviation and Complaint review, investigation and implementation as needed
- Lead and execute internal audits, ensuring timely closure of audit findings and corrective actions.
- Collect, analyze, and report on quality metrics and key performance indicators (KPIs) to track quality trends, identify areas for improvement, and support data-driven decision-making.
- Provide training to employees on quality procedures, best practices, and quality tools to enhance awareness and understanding of quality requirements and expectations.
Qualifications
Baseline skills/experiences/attributes:
- Bachelor’s degree in Chemistry, Biochemistry, Biology, or related science discipline
- Minimum five years of experience in in PLM system administration or product lifecycle management, preferably in the medical device or IVD industry.
- Previous PLM system set up experience, such as Omnify Empower or similar
- Previous experience implementing ERP System and PLM System plugins/linkage
- Strong knowledge of eQMS such as Master Control or similar
- Previous experience planning and implementing new eQMS is a plus
- Effective communication and interpersonal skills, with the ability to interact with stakeholders at all levels of the organization.
- Attention to detail, good organizational skills and team-oriented
The estimated base salary range for this role based in the United States of America is: $120,000 - $135,000. Compensation decisions are dependent on several factors including, but not limited to, level of the position, an individual’s skills, knowledge and abilities, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all full-time employees are eligible for our discretionary bonus program and equity as part of the compensation package.
For this role, we provide visa assistance for qualified candidates.
Quantum-Si does not accept agency resumes.
Quantum-Si is an E-Verify and equal opportunity employer regardless of race, color, ancestry, religion, gender, national origin, sexual orientation, age, citizenship, marital status, disability or Veteran status. All your information will be kept confidential according to EEO guidelines.
