Quality Lead

Primary Responsibilities

- Maintains product quality by enforcing quality assurance policies and procedures and applicable government requirements; collaborating with other members of management to develop new product and engineering designs and manufacturing and training methods.

- Performs and documents Change Control Request (CCR) assessments.

- Performs and documents timely Corrective and Preventive Actions (CAPA) investigations.

- Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation.

- Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines.

- Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regard to non-conformances, supplier changes, etc.

- Performs product support for product development and commercial products (reviews/approves product specifications, customer drawings, product validations protocols).

- Performs statistical data analysis utilizing statistical software (Minitab and Excel).

- Develops and implements statistical methods and designs experiments to support process control and process/product improvement.

- Performs physical and visual Test Method Validation/Gage R & R activities by developing and executing protocols for new or existing processes.

- Performs Risk Management activities utilizing risk management tools (pFMEAs (Process Failure Mode and Effect Analysis), control plans, etc.).

- Supports development and implementation of methods for sampling, inspection, testing and evaluation of products.

- Interfaces with customers to provide technical support for our products/complaints/change control.

- Reviews/approves applicable validation and qualification documents for compliance with internal procedures (Installation Qualification (IQ), Operational Qualification (OQ), Internal Product Development Process (IPDP) phase transfer documents, Document Control Revisions (DCRs), etc.)

- Supports the maintenance of the Central File and off-site documentation storage facilities.

- Implements and maintains the QMS documentation system and associated processes in accordance with departmental and company objectives while ensuring compliance to applicable standards, regulatory and customer requirements and overall protection of company intellectual property.

- Maintains secure control of internal and external documentation in accordance with the QMS and creates, revises and archives processes for the QMS documents and records.

- Creates and updates Standard Operating Procedures (SOPs), Work Instructions (WIs), Internal Test Methods (ITMs), and Internal Specifications following established processes to ensure revision control records are maintained.

- Interfaces with internal population manually and/or electronically for QMS documents.

- Assists in ensuring compliance to the record retention and destruction requirements for the QMS.

- Supports customer and/or third-party audits as required.

- May be trained as an auditor and perform quality audits.

- Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations.

- Provides coaching, feedback and guidance to team members on a continual basis and takes an active role in developing, monitoring and updating a career plan for advancement.

- Completes performance appraisals and reviews with employees; recommends salary increases to management and HR.

- May provide input to the department budgeting process and monitors and controls expenses through the year to meet budget requirements.

Other Duties

- Adheres to QMS requirements and follows applicable QMS documentation (e.g., SOPs, Work Instructions) to successfully accomplish job requirements.

- Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.

- Follows gowning procedures in designated areas.

- Follows established safety requirements and adheres to the Health Safety and Environment Management System.

- Performs other job-related responsibilities as assigned.

Qualifications

- Bachelors degree in one or more of the following - Life sciences Engineering, Engineering, Quality, Life sciences.

- 5 - 7 years experience

- Experience in life sciences/GMP industry in one or more of the following functions: Quality Assurance, Quality Engineering, Validation, Product Development, Process Engineering or Manufacturing Engineering.

- Language fluency in English and Spanish

- Knowledge of applicable regulatory standards, specifically ISO 13485

- Able to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

- Strong problem solving and analytical skills, with concentration on risk analysis.

- Demonstrated project organizational skills required.

- Strong written and verbal communication skills.

- Ability to apply principles of scientific thinking to a wide range of intellectual and practical problems; deal with nonverbal symbolism (e.g., formulas, scientific equations, graphs); deal with a variety of abstract and concrete variables.

- Demonstrated ability to participate in and/or lead cross functional teams, ability to independently prioritize and execute projects and responsibilities.

- Intermediate to advanced knowledge of MS Office Suite and statistical software (e.g., Minitab).

- Knowledge of statistics, design of experiments, sampling, gage R&R, FMEA/risk management, and process control.

- Excellent customer service focus and professionalism.

- Certified Six Sigma Greenbelt preferred.

- Certified ISO 13485 internal auditor preferred.

Competencies

- Attention to Detail: Working in a conscientious, consistent, and thorough manner.

- Customer Focus: Providing service excellence to customers and/or internal partners.

- Teamwork and Collaboration: Working collaboratively with others to achieve organizational goals, within and beyond ones area.

- Thinking Strategically: Seeing and synthesizing different sides of an issue, examining the full range of options and outcomes, and building intellectual frameworks to guide analysis and action.

- Adaptability: Adapting in order to work effectively in ambiguous or changing situations, and with diverse individuals and groups.

- Quality Engineering Principles: Applies engineering principles and techniques in the development, application, validation and maintenance of quality management systems and manufacturing. Knowledge of capability analysis, FMEA/risk management, process control, test method validation.

- Quality Steering/Standard Focus: Understand and apply quality assurance concepts, practices, tools, and techniques to ensure compliance with organizational policies and standards and to satisfy customers. When quality problems occur, take actions to solve them and/or notify/escalate as appropriate.