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Manufacturing & QA

Sr. Quality Manager

Sr. Quality Manager Senior Quality Manager SUMMARY: The hands-on Quality Manager

2019-06-10 2020
QualStaff Resources
Position: Sr. Quality Manager Salary: Unspecified Type: Full Time Location: San Diego, CA
Senior Quality Manager
SUMMARY:
The hands-on Quality Manager will be responsible for managing a team of quality professionals assessing the performance
of people and guide them for further individual development and setting goals for the function. Responsibilities include
developing and implementing systems to ensure products are designed and produced to meet Quality specifications.
ESSENTIAL FUNCTIONS:
Develop and support design transfer activities by implementing standardized quality centric launch practices that enable
business strategies.
Create Quality awareness level as determined within the organization.
Act as a contact person for ongoing NPD Projects to make sure to provide right amount of resources.
Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related
activities during the product/system lifecycle.
Ensure compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products
and operations are consistent with those regulations.
Manages the review and approval of finished products manufactured for and by the company in accordance with their
approved specifications.
Oversee all inspections and questions relating to the Quality operation of our contract manufacturer.
Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product
compliant activities and processes.
Support and attend to internal and external Audits for the organization.
Author, review and approve SOPs, protocols, reports, and other quality and regulated records for accuracy and compliance
with all applicable regulations, international standards, and internal procedures.
Maintain Quality Activities - deviations, non-conformances, CAPAs, customer complaints, process change controls, recalls,
etc.
Conduct investigations for corrective and preventive action (CAPA).
Evaluate deviations, non-conformances, out of specifications, customer complaints and process change controls for
completeness and impact on product quality.
Review, consult, and approve risk analysis performed for ECOs, NCMRs, recalls, etc.
Work with operations on the implementation of process programs and controls.
Investigate and works with other departments to resolve quality issues related to area assigned.
Lead the review of validations.
Oversee internal and external compliance audits.
Review records and data for product release.
Oversee Quality system training and lead in the development of training programs regarding all aspects of producing
quality products.
Performs trending of established quality metrics.
Act as an agent of positive change, innovation and continuous quality improvement, with the ability to influence across
functions.
ADDITIONAL DUTIES:
Plan and schedule projects in a manner consistent with corporate objectives.
Work with product development staff to ensure that products under development are compliant with FDA and ISO
requirements.
May perform additional duties as assigned or directed by management from time to time
EDUCATION/EXPERIENCE REQUIRED:
Bachelor’s degree in life science or related field or the equivalent combination of education and/or experience. Engineering
degree preferred.
5-10 years’ quality experience in biotech or Medical Device/IVD industries (GMP regulated environment) working in a
Quality Assurance role, with 2-3 years’ experience leading teams or people.
REQUIRED SKILLS:
High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work
independently with minimal direction.
Excellent communications and presentation skills.
Ability to develop and manage a high performance team focused on accountability and meeting and exceeding
expectations.
Ability to lead, influence, create and work within cross-functional team environments.
Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency
to get things done.
REQUIRED COMPETENCIES:
Performance Orientation – Is driven by personal performance; achieves all objectives detailed in Department goals and
comfortable with quantifiable assessments.
Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
Competitive – Dedicated to a competitive spirit that supports the goal to be the premier Medical Device company in the
industry.
Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain
composure and focus in situations of ambiguity and uncertainty.
Confidence - Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to
finish especially in the face of resistance or setbacks.
Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
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This job is no longer available, please consider other positions.

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