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, 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 and AS certifications
- Responsible for creation, implementation and maintenance of the Quality System processes, in compliance FDA 21 CFR, Part 820, Quality System Regulation
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.Expertise in implementing SPC, RCA, (bucket analysis), PFMEA, MSA, and yield improvement.Familiarity with AIAG (APQP, PPAP) toolbox and methods.Required Education and Experience
Bachelor’s degree in quality, engineering or a related technical field preferredMinimum 10 years experiencing in a manufacturing environment with 5 years' experience in progressive leadership and management roles in a contract manufacturing environment preferredExpertise in implementing SPC, RCA (bucket analysis), PFMEA, MSA and yield improvementFamiliarity with AIAG (APQP, PPAP) toolbox and methodsExcellent communication and organizational skillsAbility to work in a fast-paced environment with multiple prioritiesDemonstrated leadership behaviors including effective communication, critical thinking and decision making, change agent and a strong sense of urgencyProven experience leading continuous improvement initiativesExperience utilizing problem solving and root cause analysis methodsGreen Belt or Black Belt certification preferredLead Quality Auditor trainingExperience as a management representative with FDA 21 CFR 820, and / or AS9100High proficiency in use of computer programs including Outlook, Excel, Word, ERP, etc.Experience working with QMS and ERP systems i.e. Epicor ERPNecessary Skills, Abilities and Knowledge
Thorough knowledge and understanding of Quality philosophies, principles, methods, and toolsKnowledge and understanding of 21 CFR Part 820Proficiency with Microsoft Office applications, including Word, Excel, and PowerPointAbility to communicate extremely well across all levels and departments of a businessDrive organizational changeAbility to lead and develop personnelStrong interpersonal skills Self-motivated with high degree of accountabilityStrong Analytical skills and the ability to express concepts effectively, both written and verbalHighly skilled in decision making and problem solvingFinancial Management and Business Acumen mindedChange agent and ability to work with a diverse group of peopleStrong managerial leadership and communication proficiency with the ability to motivate and lead others.Hands on experience with ERP and Quality System software preferredAdditional 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.
