Snr Quality Engineer

Job Description

Job Description

Objective

This position is responsible to develop and implement systems to ensure products or services are designed and produced to meet or exceed customer expectations and regulatory requirements including the US Food and Drug Administration, Health Canada, European MDD / MDR and others as required. This role will also be participating in the implementation of improvements to the company’s quality management system procedures including, but not limited to, training, change control, document retention, Nonconformance Material processes (OOS), internal / external audits, Customer Complaint handling, post market surveillance, KPIs / metrics, Supplier Management, process validation, design quality, risk management, engineering specifications / drawings, environmental monitoring, final release, and other quality engineering duties. Under general direction, will be assessing the quality of specification and technical design documents, provide quality engineering support in the design and development of medical device products to assist in meeting department and company objectives, evaluate chemical and physical QC results of multiple substances in accordance with applicable medical device and drug regulations worldwide. In addition, this role will be responsible for mentoring others in performing thorough multiple quality processes mentioned above.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Assist to management in establishing, implementing and maintaining the quality management system.
• Drives supplier quality improvement by providing engineering analysis related to component specifications and root cause analysis. Partners with key suppliers and manufacturing personnel to reduce defects and improve yield. Participate in supplier selection and qualification processes, including supplier quality audits.
• Manages the Corrective and Preventive Action (CAPA) system and ensures timely and effective action is taken. Provide quality engineering support for manufacturing support to resolve in-house quality concerns.
• Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes. Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations.
• Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure that product development projects and changes to existing products are conducted in compliance with the applicable Quality and Regulatory requirement.
• Provide quality engineering insight and guidance on product development, product improvement and process improvement projects. Ensures validation of key design inputs including usability, reliability, performance, manufacturability, safety and effectiveness.
• Assist with quality aspects of the successful transfer of new products to production. Create protocols and reports for product, process and equipment qualifications and validations; review production processes for validation and oversee testing and analysis for standards and product requirements compliance.
• Provide training to project teams on procedures, verification, validation, statistical methods, and design controls.
• Provide quality engineering insight and guidance on product development, product improvement and process improvement projects. Ensures validation of key design inputs including usability, reliability, performance, manufacturability, safety and effectiveness.
• Provide guidance and direction for sample size and statistical analysis of verification and validation test results. Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
• Develops processes for the effective generation of metrics, including established Key Process Indicators, for use within the Quality Department Monitor quality data reporting systems. Contributes information and analysis to strategic plans and reviews; preparing and completing action plans; implementing appropriate countermeasures for KPI’s, identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Provide input and present to Management Review as required.
• Responsible for continual improvement activities to enhance the quality system, such as 5S and Kaizen lean methods.
• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Regulation, US FDA, MDSAP and others as required.
• Supports computer system validation and stays current with validation regulatory requirements.
• Monitor employee performance and ensure accuracy of employee work. Initiate or suggest plans to maximize use of manpower, and / or take corrective action to resolve errors, as applicable.
• Manage and assign resources to address business needs, including staffing levels, overtime needs and project support, as applicable.
• Monitor the workflow in the department to ensure accomplishment of projects and / or tasks and provide input on progress and performance, as applicable.
• Responsible for coordinating, collecting and testing a wide variety of materials and water per applicable pharma regulations / standards, review tests results per stablished procedures / specifications in a timely manner, as applicable.
• Evaluate raw materials that arrive daily to ensure they meet quality standards and project specifications, as applicable.
• Performs / coordinate stability tests per applicable regulations and standards.
• Expected to lead Out of Specification and non-conformities specifications.
• Oversee and perform the day-to-day activities related to Environmental Monitoring, product release testing, and contamination control
• Perform internal and / or supplier audits (travel up to 20%).
• Participate in special projects and provide support of QC inspection functions and systems, update applicable SOPs as required.

Additional Duties and Responsibilities include the following. Other duties may be assigned.

Supervisory Responsibilities

Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include planning, assigning, directing, and approving work; addressing complaints and resolving problems; interviewing, hiring, and training of employees and the performance appraisal process; and rewarding and disciplining employees

Education and / or Experience

BS in chemistry, engineering, or related field; Typically 6 -8 or more years of increasing responsibility in terms of any applicable professional experience. Minimum of three years of quality engineering experience in a medical device capacity is required. Working knowledge of ISO 9001, ISO 13485; and skill in statistical methods, including ANOVA, statistical process control, sampling plans, gauge R&R, and design of experiments (DOE) is desirable.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and / or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional & technical journals and procedures and governmental regulations. Ability to write reports, business correspondence, or procedures and prepare documentation. Ability to effectively present information and respond to questions from groups of managers or technical peer groups

Mathematical Skills

Ability to comprehend and apply mathematical concepts as required by the position, and ability to perform statistical analysis

Computer Skills

Ability to use word processing, spreadsheet and database applications. Ability to learn various software programs.

Certificates, Licenses, Registrations

ASQ-CQE, CQA and Six Sigma certifications are desirable.

Knowledge, Skills, and Abilities

Knowledge of and experience with test methods and standards for the design, verification, and validation of medical device products.

Knowledge of auditing experience with the applicable medical regulatory requirement, ISO-13485, MDSAP

Knowledge of and experience in working with risk evaluation techniques, such as FMEA & fault tree analysis.

Skill in test plan development and root cause failure analysis.

Ability to demonstrate excellent oral, presentation, and written communication skills, especially technical report writing

Ability to effectively work on project teams

Ability to interface with many levels of employees of various disciplines within various departments

Ability to maintain accuracy, consistency and quality of documentation and projects while managing assignments in a fast-paced, multi-task environment.

Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data.

Ability to take initiative and make decisions within department / company guidelines

Ability to prioritize and manage concurrent projects or tasks and coordinate work activities of others as directed.

Ability to use MS Office, and operate various other office equipment

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, hear, and use hands repetitively. The employee is occasionally required to stand; walk; to lift and / or move up to 25 pounds; travel up to 20%; and is occasionally exposed to moving mechanical parts, and dust and organic fumes such as xylene and isopropanol. Normal 20 / 20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is usually moderate.

This position is subject to the Cal OSHA requirement that employers offer the Hepatitis B vaccination series to all workers who have occupational exposure to the Hepatitis B Virus (HBV), at no cost to the workers and on company time. Workers in this position may come in contact with bloodborne pathogens that carry the risk of transmitting the HBV infection as defined in the Federal Bloodborne Pathogens OSHA standard, 29 CFR 1910.1030 and / or California Code of Regulations, Title 8, Section 5193, subsections d through h.

The posted range for this position is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location / labor market, internal equity, etc.

Clinician's Choice offers a complete benefits package, including Medical / Dental / Vision / Rx, Company Paid and Optional Life Insurance, 401(k) with matching contribution, Vacation, Sick Pay 10 paid company Holidays (or Float Days), Bereavement, Jury Duty Pay, Employee Assistance Program and employee discounts.

Clinician's Choice, a division of DenMat Holdings, LLC is an Equal Opportunity / Affirmative Action Employer; employment is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, creed, national origin / ethnicity, veteran status, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital status, or any other legally protected status.

Clinician's Choice participates in E-Verify.