Coordinate the development and administration of the company’s quality assurance (QA) system throughout the organization, in accordance with customer and company requirements. Responsible for establishing quality assurance policies and procedures as they relate to ISO, QS and other related registrations. Lead an internal audit team to support registrations.
- Actively promote and drive a culture of safety.
- Develop and manage SPG, MN’s quality system and quality personnel to achieve SPG, MN’s On-Time Delivery, Complaint Rate and Cost of Poor-Quality objectives.
- Daily supervision & engagement with the metrology lab to ensure product realization commitments are met
- Manage and represent a quality management system that maintains SPG, MN’s quality registrations (ISO 9001, ISO 13485, 21 CFR Part 820 and AS9100), is compliant with applicable local, state, and federal regulations related to SPG, MN’s product quality, ensures quality engineers achieve agreed upon customer quality requirements through routine progress meetings , and coaches, mentors and drives continuous quality improvement.
- Manage Quality Assurance team and indirect functions to achieve SPG, MN’s business and quality objectives.
Promote a safe work environment.
- Lead by example in support of a SPG values: We are passionate about: The lives our products touch, Safety, Quality & Compliance, Customers, and delivering results.
- Foster a culture of mutual respect, honesty, communication, and teamwork.
- Provide continuous feedback to subordinates and co-workers.
- Continuously evaluate voluntary standards (ISO, AS), quality regulatory requirements (FDA, MDR), and customer requirements to evaluate and maintain quality system and its policies and procedures accordingly.
- Act as Management Representative for all Quality Systems matters.
- Establish and maintain procedures and policies which maintain SPG’s quality systems.
- Provide the management team and others with regular reports against quality objectives.
- Conduct Quarterly Management Review meeting and issue the review minutes.
- Conduct the SPG, MN Internal Audits and publish the results.
- Manage the Customer Complaint system and any corrective actions arising from a complaint.
- Manage the Corrective Action/Preventive Action system (CAPA).
- Host all customer quality surveys and respond to any corrective actions that may arise from them.
Manage the Quality Engineers involvement from purchase order receipt to shipment of product including but not limited to:
- First Article Inspection function including defining activities, staffing levels, continuous feedback and timely job performance reviews, and goal setting.
- Manage the Quality Inspection function including oversight of defining activities, staffing levels, continuous feedback and timely job performance reviews, and goal setting.
- Mentor the Quality Engineering function including defining activities, providing continuous feedback, and providing input for goal setting.
- Support Sales during the quotation process by reviewing quality requirements and estimating SPG, MN’s cost to comply.
- Develop and provide input to management for the QA departmental expense and capital budgets and manage them once they are approved.
- Support SPG, MN’s improvement process by providing training in problem solving and improvement methodology (5S, Root cause Analysis, Process FMEA).
EXPERIENCE, SKILLS, EDUCATION AND TRAINING:
- Bachelor’s Degree (B.S.) from four-year college or university; and five years related experience and/or training; or equivalent combination of education and experience.
- Ability to read, analyze, and interpret common scientific and technical journals, blueprints, financial reports, and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies including Food and Drug Administration (FDA) and Federal Acquisition Regulation (FAR) representatives/agencies, members of the business community.
- Ability to effectively present information to top management.
- Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.
- Ability to define problems, collect data, investigate to establish facts, Root Cause, corrective actions and draw valid conclusions based on evaluation of effectiveness data.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form such as Geometric dimensioning and tolerancing facilitating abstract and concrete variables.
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