Quality Systems and Compliance Manager

Be visionary

Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense factory automation air and water quality environmental monitoring electronics design and development oceanographic research deepwater oil and gas exploration and production medical imaging and pharmaceutical research.

We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

Job Description

• Establish implement maintain and continuously improve the organizations QMS in compliance with ISO 9001 ISO 13485 EU MDR applicable national regulations and company requirements.
• Serve as management representative or designated quality leader to ensure QMS processes are effectively established implemented maintained and reported to executive management.
• Monitor QMS performance through quality objectives KPIs trend analysis and management review reporting.
• Ensure appropriate process interactions documented information and quality records are maintained and controlled.

• Ensure compliance with applicable medical device regulations including EU MDR 2017/745 FDA Quality System Regulation (as applicable) and other global regulatory requirements.
• Support regulatory inspections notified body audits customer audits certification audits and governmental inspections.
• Ensure quality system procedures support technical documentation device lifecycle controls vigilance reporting and post-market surveillance requirements.
• Support regulatory submissions and product registrations through quality system compliance activities.

• Promote application of risk-based thinking throughout the organization.
• Ensure quality activities incorporate risk management principles in accordance with ISO 14971 where applicable.
• Review and monitor quality risks related to products processes suppliers complaints nonconformities and field performance.
• Ensure risk controls remain effective and are periodically evaluated.

• Establish and maintain quality plans inspection strategies acceptance criteria validation activities and process controls.
• Ensure appropriate verification validation qualification and monitoring activities are performed and documented.
• Review manufacturing inspection testing and service processes to ensure compliance with established requirements.
• Support design and development activities by participating in design reviews verification validation and design transfer activities.

• Establish and maintain supplier qualification monitoring re-evaluation and approval programs.
• Conduct supplier audits and assessments using risk-based methodologies.
• Ensure supplier quality agreements change notification requirements and performance monitoring systems are implemented and maintained.
• Monitor supplier performance metrics and oversee supplier corrective action activities.

• Oversee nonconformance management root cause investigations corrective actions preventive actions and effectiveness verification activities.
• Ensure timely resolution of quality issues using appropriate problem-solving methodologies.
• Identify opportunities for continual improvement using data analysis trend analysis risk assessment Lean principles and process improvement tools.
• Monitor effectiveness of quality improvement initiatives and report results to leadership.

• Develop and maintain internal audit programs compliant with ISO 9001 ISO 13485 and MDR requirements.
• Coordinate internal supplier customer and certification audits.
• Ensure audit findings are investigated corrected and effectively closed.
• Prepare and present management review data including audit results customer feedback process performance supplier performance CAPA status complaints risk management activities and regulatory compliance status.

• Ensure customer complaints feedback returns and field issues are evaluated and investigated in accordance with applicable requirements.
• Support complaint handling vigilance reporting adverse event reporting and field corrective actions as required.
• Monitor product performance data and post-market surveillance activities to identify trends and improvement opportunities.
• Ensure customer satisfaction data is analyzed and communicated to management.

• Ensure personnel are trained and competent to perform assigned activities.
• Promote awareness of quality policy quality objectives customer requirements regulatory obligations and MDR requirements throughout the organization.
• Mentor and develop quality personnel while promoting a culture of quality and continuous improvement.

• Provide leadership and direction to quality personnel and cross-functional teams.
• Develop departmental goals budgets resource plans and improvement strategies.
• Support strategic business objectives while ensuring compliance with quality and regulatory requirements.
• Interface with executive leadership regarding quality performance regulatory risks compliance status and improvement initiatives.

• Strong knowledge of ISO 9001:2015 requirements.
• Strong knowledge of ISO 13485:2016 requirements.
• Knowledge of EU MDR 2017/745 requirements.
• Knowledge of ISO 14971 risk management principles.
• Internal auditing experience to ISO 9001 and ISO 13485.
• CAPA root cause analysis and risk management expertise.
• Supplier quality management and auditing experience.
• Strong regulatory compliance and inspection readiness skills.
• Data analysis statistical methods and quality metric development experience.
• Effective leadership communication and organizational skills.

• Medical device industry experience.
• ISO 13485 lead auditor or internal auditor certification.
• ASQ Certified Quality Manager (CMQ/OE) Certified Quality Engineer (CQE) or equivalent certification.
• Experience supporting Notified Body FDA customer and certification audits.
• Experience with MDR technical documentation post-market surveillance and supplier quality programs.

• Follows all import/export requirements consulting with facility import/export personnel as required.

• Working knowledge of Lean Manufacturing/6 Sigma/Kaizen
• Knowledge of specific software (MS Office Dynamics AX/CRM Power Bi)

• Candidate must possess U.S. citizenship or be a U.S. Person. (A U.S. Person is defined as a person who is a lawful permanent resident Green Card holder as defined by 8 U.S.C. 1101 (a)(20) or who is a Protected Individual as defined by 8 U.S.C. 1324b(a)(3).

Salary Range:

The anticipated salary range listed for this role is only an estimate. Actual compensation for successful candidates is carefully determined based on several factors including but not limited to location education/training work experience key skills and type of position.

Teledyne conducts background checks on qualified applicants who receive a conditional offer of employment in accordance with applicable laws regulations and ordinances. Background checks may include but are not limited to education verification employment history and verification criminal convictions Motor Vehicle Report (MVR & driving history) reference check credit checks/credit history and drug testing. All qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws regulations rules and regulatory orders. Our reputation for honesty integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or veteran status age or any other characteristic or non-merit based factor made unlawful by federal state or local laws.