Description
Job Summary:
Oversees all aspects of the Company’s Quality management system. Ensures compliance with applicable standards including ISO certification, FDA and relevant foreign country regulations along with customer requirements across the design, manufacture, provision and support of the Company’s products. The Quality leader will develop the Company’s Quality strategy to support the highest standards of quality appropriate to the Company’s business. This position will work collaboratively across the business to ensure successful, efficient and timely development, delivery and support for the Company’s products and will establish and communicate Quality strategy to accomplish appropriate Quality goals. Partners with internal cross-functional teams to achieve quality goals and establishes and promotes a quality compliance culture across the organization.
Key Responsibilities & Duties:
- Develops, communicates and administer an efficient and effective risk based and phase appropriate Quality Management System (QMS) in compliance with the global regulatory requirements and industry-recognized best practices for life science suppliers.
- Partner across the organization to define and implement a clear quality vision and strategic plan to support company’s goals for the development, manufacture, and support of company’s products.
- Timely and effectively supports all Quality aspects of Product Lifecycle Management including Engineering Change Management, New Product Development and Introduction (NPDI) and Product Obsolescence.
- Works closely with new product development teams to establish project quality targets and quality requirements. Leads Quality Assurance of products throughout the product lifecycle. Oversees completion of appropriate documentation to support verification, validation, and release testing procedures.
- Establish key performance indicators in alignment with company and operational goals; maintain and report applicable department and Quality System metrics and take proactive actions on adverse trends.
- Proactively identify, assess, and mitigate quality, operational, and organization risks; escalate key risks and issues.
- Leads the Quality management function and the Quality team. Attracts, maintains and develops a strong Quality team through mentoring, training and employee development opportunities. Continually develops internal team members through cross-training, career development, and succession planning. Identifies opportunities to delegate appropriately.
- Fosters a Quality focused culture across the organization, including awareness and commitment to quality goals in every aspect of product development, manufacture, delivery and support.
- Drive a culture of continuous improvement and operational excellence and instill strong ownership and accountability at all levels of the organization. Oversees and ensures the compliance of suppliers with the Company’s quality standards.
- Leads and ensures completion of all audits and compliance assessments; oversees the development and implementation of the Company’s internal systems for quality assurance and scales those capabilities in alignment with the company’s growth.
- Ensures that the QMS demonstrates regulatory compliance with applicable regulations and maintains on-going certification to all relevant regulatory bodies. Oversees activities for external audits including certification auditors, customers, and/or regulatory bodies.
- Manages, develops and/or oversees the Quality team’s responses to all QMS issues to timely close including; non-conformances, performance of Risk Assessments, CAPA investigation and support, design validation, QMS improvements and enhancements, NCR’s, compliance with regulations, policies, procedures, external and internal audits, Technical support issues, etc. Evaluates and oversees the initiation of investigative activities, corrections, and risk analysis processes.
- Defines, drives, and monitor annual Quality Plan improvement efforts.
- Takes ownership in leading, managing, and evaluating investigations related to customer complaints, nonconformances, audits, corrective/preventive action concerns, deviations, recalls, hazard assessments and ensures timely close-out of all issues.
- Champions continuous improvement in product/service quality, customer satisfaction, and company profitability. Oversees implementation and continuous improvement of quality system policies and procedures; including delivery of training to meet best practice standards.
- Participates in key strategic projects and provides leadership with periodic quality performance assessments.
- Enforces all relevant health, safety, and environmental policies (i.e., EHS, OSHA) in their span of control to ensure compliance and promote a safe working environment.
Requirements:
- Minimum bachelor’s degree in a science or engineering discipline with 10+ years of relevant quality experience/training including comprehensive knowledge:
- In Quality Assurance activities preferably supporting a life sciences manufacturing technology, or cGMP Medical Device/Pharmaceutical environment.
- Thorough knowledge of standards and regulations (cGMP, ISO 9001, and 13485, FDA Title 21 CFR Part 11, GCP/GLP/CLIA)
- 5+ years of demonstrated knowledge of current industry quality practices under ISO 9001, 13485, 21 CFR Part 11 and 21 CFR Part 820 preferred (ASQ Certifications preferred but not required).
- Prior experience in product lifecycle management desirable.
- Strong problem-solving skills including use of industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issues. Working knowledge of quality tools such as SPC (Statistical Process Control), FMEA, Root Cause Analysis, Lean manufacturing, Kaizen, Poka-Yoke, and other Six Sigma tools.
- Leadership experience in a complex quality assurance/quality systems field including leading through influence, innovative practices, and coaching skills to foster a corporate culture of responsiveness, compliance awareness, quality system ownership, and continuous improvement in order to achieve the highest level of compliance.
- Possesses a strong scientific and technical background, sufficient to establish credibility with peers and senior management particularly with manufacturing and product development teams.
- Excellent interpersonal, verbal, and written communication skills. Proven track record and experience in building and cultivating strong relationships.
- Highly organized with proven strategy/planning, project management, time management and prioritization skills. High degree of attention to detail. Strong analytical and decision-making skills.
- Ability to work independently and with minimal supervision.
- Ability to handle the pressure of meeting fixed deadlines.
- Demonstrated knowledge of quality and regulatory standards and processes, predominantly in FDA-regulated environments.
- Demonstrated leader with a strong results orientation, positive “hands-on” attitude and a strong bias towards setting and hitting deadlines.
- Ability to travel up to 20% (Domestic and International).
Position is eligible for Bonus and Equity.
Note: To the extent permissible under applicable law, candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.
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