Manager Statistical Programming Jobs in Carmel, IN

POSITION SUMMARY

The Quality Manager is responsible for leading, implementing, and continuously improving the organization's Quality Management System (QMS) to ensure product quality, regulatory compliance, operational excellence, and customer satisfaction.

This is a hands-on leadership role responsible for driving execution and delivering measurable business results. The Quality Manager works directly with Operations, Engineering, Supply Chain, and customers to solve problems, improve manufacturing processes, reduce risk, and ensure quality is built into every stage of production—not inspected into products after the fact.

The successful candidate will spend significant time on the manufacturing floor observing processes, coaching employees, leading investigations, implementing corrective actions, verifying process discipline, and ensuring sustainable improvements are achieved. Success in this role is measured by execution, accountability, improved quality performance, and customer satisfaction.

POSITION GUIDELINES

• Lead with integrity, accountability, professionalism, and sound business judgment.
• Foster a culture of ownership, process discipline, continuous improvement, and operational excellence.
• Build prevention-based quality systems that eliminate defects through robust processes, effective controls, and risk management rather than relying primarily on inspection.
• Lead by example through visible engagement on the manufacturing floor and direct involvement in solving quality and manufacturing issues.
• Hold employees and functional leaders accountable for compliance with documented processes, quality standards, and regulatory requirements.
• Develop employees through coaching, mentoring, performance management, and effective communication.
• Remain current on industry standards, quality methodologies, customer requirements, and regulatory changes.

ESSENTIAL JOB DUTIES & RESPONSIBILITIES

1.    Quality Management System Leadership

·         Lead, maintain, and continuously improve the Quality Management System (QMS) to ensure compliance with customer, regulatory, and business requirements while driving operational excellence.

·         Serve as Management Representative for ISO 13485 and other applicable quality management systems.

·         Ensure quality systems are effectively implemented, consistently followed, and continuously improved throughout the organization.

·         Drive process discipline by ensuring quality is built into manufacturing processes rather than relying on downstream inspection.

2.    Operational Quality Leadership

·         Spend significant time on the manufacturing floor observing operations, verifying process compliance, coaching employees, identifying risks, and driving immediate corrective action.

·         Work directly with Operations and Engineering to improve manufacturing processes, reduce variation, improve yield, reduce Cost of Poor Quality (COPQ), and eliminate recurring quality issues.

·         Personally lead investigations involving customer complaints, escapes, process failures, audit findings, and significant quality events.

·         Challenge ineffective processes, remove barriers to quality performance, and ensure issues are resolved at their source.

·         Hold functional areas accountable for sustaining process improvements and complying with quality system requirements.

3.    Quality Systems & Continuous Improvement

·         Personally lead the organization's CAPA process by ensuring timely containment, thorough root cause analysis, implementation of sustainable corrective actions, and verification of long-term effectiveness.

·         Lead structured problem solving using methodologies such as 8D, 5 Whys, Fishbone, PFMEA, SPC, and statistical analysis.

·         Plan, conduct, and lead internal audits while personally verifying corrective actions are implemented and sustained.

·         Lead Management Review activities and provide leadership with accurate quality performance metrics, emerging risks, trends, and recommended actions.

4.    Metrics & Business Performance

·         Establish meaningful quality objectives and key performance indicators that measure process capability, customer satisfaction, Cost of Poor Quality (COPQ), scrap, rework, escapes, and operational performance.

·         Routinely analyze quality and operational data to identify adverse trends and lead timely corrective actions.

·         Drive data-based decision making throughout the organization using statistical analysis and objective evidence.

·         Lead risk management activities by integrating PFMEA, process controls, lessons learned, customer feedback, audit results, and operational performance data into continuous improvement initiatives.

5.    Operational Quality Systems

·         Ensure effective control of documentation, engineering changes, nonconforming material, rework, traceability, Device History Records, and quality records.

·         Verify manufacturing and quality processes are effectively controlled through documented procedures, process validation, objective evidence, and routine process verification.

·         Support New Product Introduction (NPI), process validation, production readiness, and manufacturing transfers.

6.    Customer & Supplier Quality

·         Serve as the primary quality representative for customers by leading investigations, presenting corrective actions, restoring customer confidence, and ensuring commitments are completed on time.

·         Lead customer, regulatory, certification, and third-party audits while ensuring findings are resolved promptly and corrective actions remain effective.

·         Oversee supplier quality activities, supplier development, supplier corrective actions, and supplier performance improvement.

7.    Leadership

·         Recruit, develop, coach, mentor, and evaluate Quality personnel while building a high-performing Quality organization.

·         Lead cross-functional teams to execute corrective actions, remove barriers, improve manufacturing processes, and deliver measurable business results.

·         Establish departmental priorities aligned with strategic business objectives.

8.    Other duties as assigned

QUALIFICATIONS

Experience/Background

• Minimum of 10 years of progressive quality experience in a regulated manufacturing environment (medical device preferred).
• Minimum of 5 years of leadership experience in a Quality Manager or equivalent role.
• Demonstrated success leading ISO 13485-compliant Quality Management Systems and driving measurable improvements in quality, compliance, and operational performance.
• Proven experience leading customer, regulatory, and certification audits; CAPA; root cause investigations; and continuous improvement initiatives.
• Experience working directly with Operations and Engineering to improve manufacturing processes, reduce risk, and solve complex quality issues.
• Lean Manufacturing and Six Sigma experience required; Six Sigma Green Belt or higher preferred.
• This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). Must be a U.S. person or protected individual within the meaning of ITAR. ITAR defines U.S. persons and protected individuals as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), U.S. Temporary Resident, Political Asylee, or Refugee. 

Skills

• Expert knowledge of ISO 13485, quality systems, CAPA, root cause analysis, SPC, PFMEA, and other quality improvement tools.
• Hands-on leader with the ability to identify process weaknesses, implement sustainable corrective actions, and deliver measurable results.
• Strong analytical, problem-solving, and decision-making skills with the ability to translate data into action.
• Ability to lead cross-functional teams, establish accountability, and drive execution in a fast-paced manufacturing environment.
• Excellent communication and organizational skills with the ability to build strong relationships with employees, customers, suppliers, and auditors.
• High level of professionalism, integrity, sound business judgment, and customer focus.

 Education

• Bachelor’s degree in Engineering, Quality Management, Manufacturing Engineering, Manufacturing Management or an equivalent combination of education and relevant work experience.
• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), Six Sigma Green Belt, Six Sigma Black Belt or equivalent professional certification preferred.

ENVIRONMENTAL & PHYSICAL REQUIREMENTS

Office / Sedentary Requirements

Incumbent must be able to perform the essential functions of the job. Work may be performed in an office or warehouse environment. Typically requires the ability to sit for extended periods of time (66%+ each day), ability to hear the telephone, ability to enter data on a computer and may also require the ability to lift up to 10 pounds. May have possible exposure to dust.

ADDITIONAL INFORMATION REGARDING JOB DUTIES AND JOB DESCRIPTIONS

Job duties include additional responsibilities as assigned by one’s supervisor or another manager related to the position/department. This job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Piezo Technologies reserves the right at any time with or without notice to alter or change job responsibilities, reassign, or transfer job position or assign additional job responsibilities, subject to applicable law. Piezo Technologies shall provide reasonable accommodations of known disabilities to enable a qualified applicant or employee to apply for employment, perform the essential functions of the job, or enjoy the benefits and privileges of employment as required by the law.