Title: Complaints Manager

Location: South San Francisco, CA

Terms: 12 Month Contract

Industry: Medical Device

WHY PATIENTS NEED YOU

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

WHAT YOU WILL ACHIEVE

You will be a member of a dedicated and highly effective quality assurance team helping to drive quality and deliver products that impact patients lives. You will push the development teams to deliver the highest quality products and solutions. You will work with the product development team focused on medical devices used in combination products.

ROLE SUMMARY

As a Manager within the Medical Device Quality Assurance organization, you will work with the product development teams and postmarket teams focusing on invitro diagnostic devices and medical devices. You will utilize your knowledge and skills to provide guidance to operational teams and project teams related to design controls (21 CFR 820), risk management (ISO 14971), risk assessments, internal/external audits, Corrective and Preventative Action (CAPA), and other applicable regulatory requirements for the medical device or the device constituent of combination products. You will work with the development teams and other organizations to advance new concepts and methodologies. You will take a leadership role to facilitate agreements between different teams, vendors, and organizations. The Manager will be an advocate for quality who collaborates with other functional teams reviewing design control deliverables to ensure the developed products are safe and effective.

ROLE RESPONSIBILITIES

As a Manager you will be part of the Quality Assurance team within the organization and provide quality support to R&D and Technical Operations for the development & commercialization of Medical Devices and Invitro Diagnostics. Your knowledge and skills will contribute towards the goals and objectives of the team within the requirements of the quality system and associated regulatory requirements. You are expected to be a self-directed professional who can identify issues, communicate effectively to all levels within the organization, have a focus on quality, help in completing critical deliverables, facilitate in explaining difficult issues, and establish consensus with team members.

This role has responsibility for the oversight, support and delivery of the Medical Device and Invitro Diagnostic Device portfolio in partnership with the R&D.

Organization.

Responsibilities include but not limited to:

Act as the quality assurance resource and quality lead supporting new product development for invitro diagnostic devices
Serves as a subject matter expert (SME) on internal procedures, regulations, regulatory guidance, and the Quality Management System.
Ensures policies and procedures related to quality assurance and compliance requirements of the company are being followed during development/lifecycle management execution.
Provide Quality Assurance support and direction to project teams, to manufacturing sites, and to device contractors.
Ensure device design/development meets appropriate regulatory requirements by providing pro-active guidance through all stages of development in accordance with 21 CFR 820, ISO 13485, IEC 62366, IEC62304, ISO 14971, and MDCP procedures.
Lead quality discussion and use breadth of knowledge to contribute to broader device development strategies and decisions.
Generate and interpret metrics to support continuous improved of the business.
Well versed in quality investigation techniques and acts as quality lead for investigations.
Responsible for communication and escalation of quality issues within Pfizer
Responsible for working with external contractors related to medical device products to ensure consistency and compliance with regulatory expectations and company standards including leading and supporting investigations of significant quality and/or regulatory events associated with external suppliers
Support the Vendor management quality system for assigned vendors.
Mentor, develop, train, and coach junior Quality Assurance employees, project teams, and other Pfizer personnel
Contribute significantly to establishing, maintaining, and revising internal procedures

BASIC QUALIFICATIONS:

Technical knowledge related to the design/operation of medical device or product platforms, design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, IVDD / IVDR, and MDR.
5+ years' experience of working in a Quality Assurance, the pharmaceutical industry, GMP manufacturing, or Medical Device role.
Experience in the design and development of medical devices.
Experience interacting with FDA investigators and other regulatory agencies audits.
Knowledge and application of device root cause analysis methodology and device CAPA requirements
Experience in change management of either medical devices

PREFERRED QUALIFICATIONS:

Extensive knowledge of cGMPs with a broad understanding of scientific principles associated with product development.
Thorough understanding and application of cGMP specifically 21 CFR 820 and the principles and concepts of relevant quality processes and systems.
Strong leadership, negotiation, interpersonal, communication, and facilitation skills.
Extensive experience in risk management and design control of medical devices from concept through launch
Proven ability to succeed in a fast-paced, challenging, and complex environment.
Experienced leading a team
Proven ability to mentor engineers
ASQ CQE Certification
ISO 13485 Lead Auditor Certification

SKILLS:

Strong leadership, negotiation, interpersonal, communication, and facilitation skills
Comfortable working and making risk-based decisions
Develops good working relationships with diverse teams
Dedicated to problem solving and meeting the expectations of internal and external customers
Ability to lead and deliver in a matrix environment
Prior experience in management of external vendors and suppliers
Prior experience of SOP interpretation and performing gap analysis
Understanding of device quality system principles (as well as cGMPs) and ability translate into operational use
Ability to understand Regulations, identify gaps, and create action plans to address

EOE Statement: Specialist Staffing Group 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.

To find out more about Real, please visit www.realstaffing.com

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