Quality Manager - Santa Clara, CA - Contract

Ryzen Solutions; Santa Clara (CA); Presencial; USD 125 000 - 180 000; Tempo integral

Resumo da oferta

Ryzen Solutions is seeking a Quality Manager for a Santa Clara, CA contract role with a medical device manufacturing client. You will lead Quality personnel and ensure compliance with the Quality Management System while supporting sustaining manufacturing and development programs.

The role emphasizes regulatory alignment (ISO 13485, FDA QSR), CAPA, audits, and cross-functional coaching. A BS or equivalent experience and 7+ years in a regulated environment are required; onsite work only.

Qualificações

• Minimum 7 years of experience in a regulated medical device environment.
• BS or equivalent experience; regulatory certification(s) preferred (ASQ, Lead Auditor).
• Knowledge of ISO 13485 and FDA cGMP/QSR requirements.
• Experience leading quality programs and audits with strong communication skills.

Responsabilidades

• Lead the Quality Management System oversight and compliance.
• Promote regulatory requirements and QMS awareness site-wide.
• Manage audits by customers and regulatory bodies; drive CAPA.
• Oversee Quality Control activities including inspections and product release.
• Lead Management Review meetings and report QMS performance and improvements.
• Guide QA staff and cross-functional teams; support process validation and transfers.
• Coordinate documentation control, risk management, and training.

Conhecimentos

Regulatory knowledge

Leadership

Quality systems

Cross-functional collaboration

Formação académica

Bachelor of Science or equivalent experience

Ferramentas

Microsoft Word

Microsoft Excel

PowerPoint

MS Access

PLM systems

MRP systems

Descrição da oferta de emprego

Our client who specializes in the medical device manufacturing is searching for a Quality Manager. Location: Santa Clara, CA Employment structure: Contract Work environment: 100% Onsite Start date: ASAP

Responsibilities

JOB SUMMARY The Quality Manager will be responsible for the leadership and management of Quality personnel and resources to ensure compliance to company's Quality Management System. The Quality Manager may be the designated Management Representative for the Quality Management System. The Quality Manager will also be responsible for overseeing Quality engineering activities to support sustaining manufacturing operations, and product development programs.

ESSENTIAL RESPONSIBILITIES

• Responsible for oversight and compliance of the Quality Management System.
• Responsible for ensuring that the processes needed for the Quality System requirements are established and maintained in accordance with applicable regulations and standards.
• Responsible for ensuring the promotion and awareness of applicable regulatory requirements and Quality Management System requirements throughout the site’s organization.
• Responsible for leading Management Review meetings and reporting on the performance and effectiveness of the Quality System, as well as any improvements needed, for periodic review and analysis.
• Oversee Complaint Analysis and Corrective and Preventive Action Systems, and the tracking / reporting of metrics.
• Manage Quality Control staff to provide incoming (receiving & inspection), in-process inspection, final inspection, and product release activities for all manufacturing programs.
• Responsible for overseeing or delegating the creation of QMS related Quality Plans that are site-specific.
• Depending on Cirtec site may manage Design and Development Quality staff.
• Provide organizational leadership, coaching, mentoring and guidance to all Quality personnel as well as cross-functional teams.
• Drive and support corporate Quality Management System initiatives.
• In partnership with other Quality Leaders, ensure establishment and maintenance of site registrations (e.G., ISO 13485 and FDA).
• Act as site champion for Quality Best Practices and cGMP Ensure accountability for Design Controls and DHF management of internal and customer development programs and design transfers.
• Provide Quality Engineering support for internal and customer development programs and sustaining manufacturing process/continuous improvement efforts.
• Initiate and/or collaborate in the generation/update of process / product Risk Management documentation, e.G., FMEAs and Hazard Analysis, in collaboration with cross-functional engineering teams.
• Develop and perform qualifications and validations for manufacturing processes in collaboration with cross-functional engineering teams per project requirements.
• May author, review and/or approve documentation for process and design change activities as well as validation / verification oversight and/or test method execution in cooperation with cross-functional engineering teams per project requirements.
• Represent Quality Engineering in program / project phase reviews throughout the product development and transfer to manufacturing phases and process improvement initiatives.
• Support and oversee the Nonconformance Materials Review Board process.
• Manage metrology and calibration activities.
• Primary lead for external regulatory, certification, and customer audits.
• Manage support for local and corporate Documental Control (PLM) and Material Resource Planning (MRP) systems implementations, integrations, and improvements.
• Manage Quality Systems staff to provide Documentation Control and records retention functions, Incoming/Final Inspection, Complaint Analysis, Corrective Action System and Quality Control training to Customer Focused Business Units.
• Complies with company, safety and quality standards, policies, and procedures.
• Other duties as assigned.

This is not a remote position.

Bachelor of Science or equivalent experience, preferably in an engineering discipline. Minimum 7 years of experience in a regulated medical device environment, preferably as a Sr or Principal Quality Engineer or Quality Manager, with supervisory and decision-making responsibilities. Quality and/or Regulatory certification(s) preferred (ASQ, Lead Auditor, etc.). Knowledge and experience with external standards and regulations: ISO 13485, and 21 CFR 820 (FDA cGMP/QSR), EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier auditing & management, quality control (GD&T, MRB, etc.), CAPA and customer complaints. Experience with Class II and Class III medical device development and manufacturing. Demonstrable knowledge and experience with Manufacturing Process tools/methodologies including: Process Change Assessment, Risk Management (Hazard Analysis), Process FMEA, Statistical Analysis, Process Qualification, Gauge R&R, and Inspection/Test Method Validation. Experience in effectively managing audits by customers and regulatory agencies. Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement. Strong verbal and written communication skills. Ability to present complex information to internal and external contacts. “Hands‑on”self‑starter with ability to work both independently and as part of a team. Training or equivalent experience in computer use and software-Client Word, Excel, Power Point and Access. Experience in coaching and developing direct reports, utilizing performance management tools and disciplines, while increasing employee engagement and retention.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.