Demo

Quality Director

Sanders Industries Holdings
San Clemente, CA Full Time
POSTED ON 1/30/2025
AVAILABLE BEFORE 4/30/2025

Job Description

Job Description

IPS - IRP Med is seeking a Director of Quality who leads and directs the quality function within a large business unit or group of businesses in accordance with the company's strategic objectives. Increases interdepartmental co-operation and focuses the attitude on quality. Ensures products and processes are in compliance with regulations, specifications, contract requirements, and quality system standards.

In addition, this position is responsible for recruiting, selection, training, development, and supervision of staff, providing guidance and support.

About IPS : Integrated Polymer Solutions (IPS) is a leading developer and manufacturer of advanced materials and engineered components, focused exclusively on high-value end markets such as aerospace, defense, medical, semiconductors, robotics, energy, and industrial applications. The group consists of 9 highly respected brands : AkroFire, ABBA Roller, Icon Aerospace Technology, IRP Medical, MAST Technologies, Northern Engineering Sheffield (NES), RMB Products, Rubbercraft, and Swift Textile Metalizing (STM). Our product range includes elastomeric seals, gaskets, tooling, hoses, ablatives, survivability tiles, coatings and tapes, EMI and thermal shielding, electrically conductive metalized fabrics, encapsulated O-rings, as well as polyamide foams and high-temperature thermoplastics for aircraft interiors. We also provide rotational lining for corrosion protection with seamless liners for pipelines and equipment, and additive manufacturing capabilities for advanced flight hardware production.

Job Accountabilities :

  • Implements and communicates quality policies and programs consistent with customer requirements, quality regulations, and the company procedures
  • Oversee the implementation and effectiveness of corporate and divisional QMS for compliance to any quality standards such as ISO, AS, FDA and be the liaison to the ISO registrars of each business, any federal / state / county / city regulatory agencies and internal / external quality auditors.
  • Take leadership and responsibility for any significant quality incidents / issues. Be “hands on” with the issue, develop a plan of action to resolve the issue, communicate the plan and progress to the site Senior Leadership team.
  • Partner with the Operations team to improve and maintain a culture of world class quality and customer satisfaction. The Director of Quality will be a mentor and driver of positive change within the organization.
  • Monitor customer feedback and corrective actions and make improvements to enhance the quality systems based on this feedback.
  • Analyze and evaluate quality and reliability capabilities of potential and existing suppliers, as applicable through site visits, audits, surveys and or data analysis.
  • Develop and maintain an oversight of its supply chain to ensure only high-quality suppliers are retained and or put on a corrective action plan, as applicable.
  • Have overall responsibility of the Material Review Board (MRB) process. Maintain key quality metrics to analyze and monitor performance to achieve site level goals.
  • Identify and solve bottlenecks at Incoming, In-process, and Outgoing Inspection processes.
  • Develop APQP Advanced Product Quality Plans, as appropriate.
  • Lead in the development and continuous improvement of the Internal Auditing program.
  • Establishes and maintains an organization capable of adapting to a dynamic business / manufacturing environment that focuses on continuous improvement, good communication, professionalism, and efficiency
  • Initiates and implements quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the company’s product lines
  • Serves as the primary quality control resource for problem identification, resolution, loss reporting, and continuous improvement
  • Supports concurrent engineering efforts by participating in design development projects representing quality assurance and the customer
  • Designs, implements, and documents procedures for validations, process control, process improvement, testing, and inspection
  • Establishes and implements quality metrics (process capability, control / trend charts, quality measurement) for monitoring system effectiveness and to enable managers to make sound product quality decisions
  • Evaluates internal compliance to all customer and relevant regulatory requirements, identifies areas requiring corrective action, and follows through to ensure the effectiveness of improvements
  • Manages staff selection, performance, development, and training processes to ensure team competencies and capabilities to reach business goals and expectations.
  • Responsible for hiring and terminating subordinate employees (or effectively recommending such decisions). Handling employee complaints and grievances; staff mentoring, coaching, counseling, disciplining employees; assigning work among employees; and providing for the safety and security of the employees.
  • Directing employees’ work and establishing and adjusting hours of work as needed
  • Establishes priorities and workflow within the department; identifies root cause, conducts analysis, and resolves issues with appropriate resources departments and / or action plans.
  • Provides staff with standards of performance, job responsibilities, and job expectations.
  • Conducts staff meetings to ensure policies and procedures are adhered to and enforced, and when necessary, modified to address changing strategic objectives.
  • Maintain production records for use in supervision; appraising employees’ productivity standards and efficiency for recommending promotions or other changes in status.
  • Ensures appropriate management of department staff, including timely completion of performance appraisals and corrective counseling, when appropriate.

Job Specifications :

Education : Bachelor's degree in quality assurance or any Science related field

Years’ Experience : minimum 10 years of relevant experience in a management leadership role within a manufacturing environment with a quality assurance function

Skills :

  • Demonstrated Hands-On experience and applications of quality management and ability to maintain compliance and audit readiness of the company’s QMS
  • Strong knowledge of ISO9001 is required.
  • Strong knowledge of ISO13485, ISO14971 and FDA 21 CFR Part 820 QSR / cGMP is required.
  • Strong knowledge in Data Analysis and Statistics with proficiency in utilizing Minitab statistical software program.
  • Strong knowledge in developing MSA Measurement System Analysis, executing GR&R Gauge Repeatability and Reproducibility, and establishing TMV Test Method Validations.
  • Strong knowledge in AQL sampling of product per ISO2859, ANSI / ASQ Z1.4 as well as Single, Double, and C=0 acceptance sampling.
  • Ability to communicate effectively, both written and verbal, among staff and leadership as well as customers and external regulatory authorities
  • Ability to professionally represent the company when dealing with external organizations and regulatory bodies.
  • Demonstrates ability to develop FMEA, Process Qualification and Validation Protocols and Reports.
  • Strong team development and management skills to enable the creation of a highly capable and sustainable QA Function
  • Demonstrated QA expertise, and ability to improve products or services by applying professional and business knowledge
  • Experienced with making technical and managerial decisions that will have a significant effect on products
  • Solid analytical skills and judgment to proactively identify and solve complex issues
  • Effective interpersonal, verbal, and written communication skills to drive tasks to completion
  • Demonstrates ability to analyze and determine methods and procedures
  • Ability to prioritize competing commitments in line with departmental and / or corporate objectives
  • Proficient in Microsoft Office and database management tools
  • Excellent interpersonal, written, oral communication, presentation, and facilitator skills with the ability to negotiate, influence and interact effectively with stakeholders at all levels of the organization exercising sensitivity to the audience.
  • Possesses a positive professional image and a high level of ethical behavior in exercising consistent judgment, discretion, and confidentiality in all interactions and matters of significance
  • Possesses excellent judgment, critical thinking, problem-solving, and decision-making skills with the ability to identify and resolve complex issues in a timely manner.
  • Possesses excellent leadership, team building, and managerial skills with the ability to direct, energized, motivate, train, coach, assess, evaluate and develop teams.
  • Possesses strong strategic / analytical, goal setting, budgetary management, and financial measurement skills.
  • Capable of driving change transformation and strategy execution to achieve specific business results.
  • Possess superior organizational and time management skills with strong attention to detail.
  • Ability to work independently and negotiate and set priorities required.
  • Ability to work efficiently under conditions of multiple and / or completing projects / deadlines prioritizing / reprioritizing as needed to meet departmental and / or business commitments and objectives.
  • Possesses a high degree of personal accountability
  • Ability to travel to all IPS locations and / or client locations as needed
  • Benefits :

    At Integrated Polymer Solutions, we recognize how important your career and benefits are to you and your family. We offer a full suite of benefits, including medical, dental, vision, short and long-term disability coverage, accident insurance, critical illness insurance, basic and supplemental life insurance, employee assistance plan, retirement savings and matching, and other developmental opportunities. We are committed to supporting the way you live and work.

    IPS is an Equal Opportunity Employer Veterans / Disabled - Affirmative Action Employer.

    This position requires using information subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.

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