Director of Quality

3 weeks ago

Cedar City, United States ALIGN PRECISION - CEDAR CITY, LLC Full time
Job DescriptionJob Description

Summary

The Director of Quality Assurance is responsible for developing and directing robust quality processes and procedures to ensure the products manufactured meet customer requirements and specifications, including FDA, ISO 13485 and AS compliance, as applicable. This position will develop and grow a capable team of quality assurance staff to achieve company goals and objectives.

Primary Duties

· Lead as the management representative for FDA 21 CFR 820, ISO 13485 and AS certifications

· Responsible for creation, implementation and maintenance of the Quality System processes, in compliance FDA 21 CFR, Part 820, Quality System Regulation and ISO 13485

o Systems include Corrective and Preventive Action, Non-conformance and Material Review Board, Validation and Qualification, Management Review, Document and Record Control, Risk Management Activities, Training and Resource Management, Supplier Management, Internal Audit System, Calibration, Inspection and Inspection Planning, RMA and resolve of customer complaints.

· Establish and promote a work environment that supports the company Quality Policy, Quality Objectives and Quality System.

· Develop and implement policies, procedures, and systems that support company quality goals and objectives, and maintain regulatory compliance.

· Recruit, train and manage quality control and assurance personnel including inspection and metrology.

· Provide direction, coaching and development of quality personnel.

· Lead MRB and CAPA process to reduce product non-conformances through training and effective corrective actions.

· Investigate and manage customer complaints with internal and external customers to solve quality issues through the CAPA process.

· Provide leadership on continuous improvement initiatives (lean, Six Sigma, etc.)

· Monitor and report internal and external quality metrics by collecting, analyzing and summarizing information and trends.

· Maintain validation and calibration of inspection equipment.

· Organize customer quality expectation information and contractual obligations.

· Participate in creation of DMR. Specifically assure the development of part specific inspection plans to meet customer requirements and contractual obligations.

· Develop robust, part specific, inspection processes that meet customer requirements.

· Train all employees on quality & safety procedures & monitor performance

· Support a safety oriented culture within the company

· Participate in the development of the company’s strategic planning, vision, mission and values and desired culture

Required Education and Experience

· Bachelor’s degree in Quality, Engineering or a related technical field preferred

· Minimum 10 years experiencing in a manufacturing environment with 5 years experience in progressive leadership and management roles in a contract manufacturing environment preferred

· Excellent communication and organizational skills

· Ability to work in a fast-paced environment with multiple priorities

· Demonstrated leadership behaviors including effective communication, critical thinking and decision making, change agent and a strong sense of urgency

· Proven experience leading continuous improvement initiatives

· Experience utilizing problem solving and root cause analysis methods

· Green Belt or Black Belt certification preferred

· Lead Quality Auditor training

· Experience as a management representative with FDA 21 CFR 820, ISO 13485 and/or AS9100

· High proficiency in use of computer programs including Outlook, Excel, Word, ERP, etc.

· Experience working with QMS and ERP systems i.e. Epicor ERP

Necessary Skills, Abilities and Knowledge

· Thorough knowledge and understanding of Quality philosophies, principles, methods, and tools

· Knowledge and understanding of ISO 13485 and 21 CFR Part 820

· Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint

· Ability to communicate extremely well across all levels and departments of a business

· Drive organizational change

· Ability to lead and develop personnel

· Strong interpersonal skills Self-motivated with high degree of accountability

· Strong Analytical skills and the ability to express concepts effectively, both written and verbal

· Highly skilled in decision making and problem solving

· Financial Management and Business Acumen minded

· Change agent and ability to work with a diverse group of people

· Strong managerial leadership and communication proficiency with the ability to motivate and lead others.

· Hands on experience with ERP and Quality System software preferred

Additional Notes

ALIGN PRECISION is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ALIGN PRECISION are employed on an at-will basis.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

  • Director of Quality

    3 weeks ago

    Cedar City, United States ALIGN PRECISION - CEDAR CITY, LLC Full time

    Job Description Job Description Summary The Director of Quality Assurance is responsible for developing and directing robust quality processes and procedures to ensure the products manufactured meet customer requirements and specifications, including FDA, ISO 13485 and AS compliance, as applicable. This position will develop and grow a capable team of...

  • Director of Quality

    2 weeks ago

    Cedar City, United States ALIGN PRECISION - CEDAR CITY, LLC Full time

    Job Description Job Description Summary The Director of Quality Assurance is responsible for developing and directing robust quality processes and procedures to ensure the products manufactured meet customer requirements and specifications, including FDA, ISO 13485 and AS compliance, as applicable. This position will develop and grow a capable team of...

  • Director of Quality Manufacturing

    4 weeks ago

    Cedar City, United States ALIGN PRECISION Full time

    Job DescriptionJob DescriptionSummaryThe Director of Quality Assurance is responsible for developing and directing robust quality processes and procedures to ensure the products manufactured meet customer requirements and specifications, including FDA, ISO 13485 and AS compliance, as applicable.  This position will develop and grow a capable team of quality...

  • Director of Quality Manufacturing

    2 weeks ago

    Cedar City, United States ALIGN PRECISION Full time

    Job DescriptionJob DescriptionSummaryThe Director of Quality Assurance is responsible for developing and directing robust quality processes and procedures to ensure the products manufactured meet customer requirements and specifications, including FDA, ISO 13485 and AS compliance, as applicable.  This position will develop and grow a capable team of quality...

  • Director of Quality Manufacturing

    2 weeks ago

    Cedar City, United States ALIGN PRECISION Full time

    Job DescriptionJob DescriptionSummaryThe Director of Quality Assurance is responsible for developing and directing robust quality processes and procedures to ensure the products manufactured meet customer requirements and specifications, including FDA, ISO 13485 and AS compliance, as applicable.  This position will develop and grow a capable team of quality...

  • Director, Nursing Quality and Informatics

    1 month ago

    Iowa City, United States University of Iowa Full time

    The University of Iowa Hospitals & Clinics' is seeking a Director of Nursing Quality and Informatics The Director of Nursing Quality and Informatics is responsible for leadership and administrative oversight of Nursing Quality in the adult areas of t Director, Nursing, Quality, Nurse Manager, Clinical, Healthcare

  • Director, Nursing Quality and Informatics

    1 month ago

    Iowa City, United States University of Iowa Full time

    University of Iowa Health Care is seeking a Director of Nursing Quality and Informatics The Director of Nursing Quality and Informatics is responsible for leadership and administrative oversight of Nursing Quality in the adult areas of the UI Health Care Medical Center system(including falls, hospital acquired pressure injuries [HAPI], central line...

  • Director, Nursing Quality and Informatics

    6 days ago

    Iowa City, United States University of Iowa Full time

    University of Iowa Health Care is seeking a Director of Nursing Quality and Informatics The Director of Nursing Quality and Informatics is responsible for leadership and administrative oversight of Nursing Quality in the adult areas of the UI Health Care Medical Center system(including falls, hospital acquired pressure injuries [HAPI], central line...

  • Director of Quality

    3 weeks ago

    King City, United States Bileddo Associates Full time

    Director of Quality Paso Robles Area Our client is a 100 bed not for profit hospital centrally located in California . Minutes to wine country and over 300 wineries – Live in wine country and commute into work! The Director of Quality works collaboratively with senior leadership, MMHS leaders, physicians and staff to reduce patient, guest, and employee...

  • Director Quality

    3 weeks ago

    Texas City, United States HCA Houston Healthcare Mainland Full time

    This position is incentive eligible. **Introduction**: Are you ready to manage in a new era as a Director Quality where building a healthier tomorrow is more than a job? Our HCA Houston Healthcare Mainland team is committed to partnership, innovation, legacy and improving more lives in more ways. Share your resume today. **Benefits**: HCA Houston...

  • Director Quality

    4 days ago

    Texas City, United States HCA Houston Healthcare Mainland Full time

    This position is incentive eligible. **Introduction**: Are you ready to manage in a new era as a Director Quality where building a healthier tomorrow is more than a job? Our HCA Houston Healthcare Mainland team is committed to partnership, innovation, legacy and improving more lives in more ways. Share your resume today. **Benefits**: HCA Houston...

  • Director Quality

    3 weeks ago

    Texas City, United States HCA Houston Healthcare Mainland Full time

    Description This position is incentive eligible. Introduction Are you ready to manage in a new era as a Director Quality where building a healthier tomorrow is more than a job? Our HCA Houston Healthcare Mainland team is committed to partnership, innovation, legacy and improving more lives in more ways. Share your resume today. Benefits HCA Houston...

  • Director Quality

    2 weeks ago

    Texas City, United States HCA Houston Healthcare Mainland Full time

    Description This position is incentive eligible. Introduction Are you ready to manage in a new era as a Director Quality where building a healthier tomorrow is more than a job? Our HCA Houston Healthcare Mainland team is committed to partnership, innovation, legacy and improving more lives in more ways. Share your resume today. Benefits HCA Houston...

  • Director Quality

    2 weeks ago

    Texas City, United States HCA Healthcare Full time

    Description This position is incentive eligible. IntroductionAre you ready to manage in a new era as a Director Quality where building a healthier tomorrow is more than a job? Our HCA Houston Healthcare Mainland team is committed to partnership, innovation, legacy and improving more lives in more ways. Share your resume...

  • Director of Acute Quality

    4 weeks ago

    Oklahoma City, United States tapwage Full time

    The Director of Acute Quality is responsible for system-wide acute care quality assurance, improvement, and integration throughout the organization and will report directly to the Vice President of Clinical Programs. The Director provides system subject matter expertise and collaborates with the directors of Safety, Infection Prevention, Clinical Programs,...

  • Director of Acute Quality

    4 weeks ago

    Oklahoma City, Oklahoma, United States tapwage Full time

    The Director of Acute Quality is responsible for system-wide acute care quality assurance, improvement, and integration throughout the organization and will report directly to the Vice President of Clinical Programs. The Director provides system subject matter expertise and collaborates with the directors of Safety, Infection Prevention, Clinical Programs,...

  • Director of Claims Quality

    4 weeks ago

    Jersey City, United States Tandym Group Full time

    A health services organization in New York City is currently seeking an experienced professional to join their staff as their new Director of Claims Quality. In this role, the Director of Claims Quality will be responsible for the creation, delivery and ongoing facilitation of a data and metrics-driven Claims Quality Assurance and Performance oversight...

  • Director of Quality, Engineering Analysis

    4 weeks ago

    Cedar Park, United States World Aerospace Corp Full time

    Job title: Director of Quality, Engineering Analysis Job description: Apply technical knowledge to provide solutions for airline customers seeking maintenance/repair assistance. Conduct basic and applied research to evaluate adaptability of aftermarket parts and equipment to aircraft repair needs of airline clients. Technical data verification and analysis...

  • Director Quality

    3 weeks ago

    Oklahoma City, United States INTEGRIS Health Full time

    The Director Quality and Safety The Director Quality and Safety is responsible for the development, management and evaluation of strategies, standards and programs addressing quality, patient safety and clinical performance. The Director executes programs focused on the delivery of safe, high quality healthcare and improved patient outcomes. INTEGRIS is an...

  • Director Quality Assurance Quality Control

    2 weeks ago

    Kansas City, United States Judge Direct Placement Full time

    Judge Direct Placement is seeking a degreed Director of Quality in Kansas City, KS! They will be responsible for directing company technical, regulatory/compliance, and strategic leadership for the Quality function. The qualified candidate will invent all procedures and policy to cover all aspects of Quality and work with the Plant Managers and Quality...