Manager Quality Control
Manager Quality Control
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Job Description
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day more than 4000 of us are challenging whats possible and making headway to help improve outcomes.
The Manager of Quality Control (QC) will oversee the daytoday operations of the QC department ensuring that all medical devices meet regulatory standards and customer specifications. This role requires strong leadership technical expertise and a deep understanding of all global quality regulations and standards in the medical device industry. The QC Manager will work crossfunctionally with other departments to support continuous improvement initiatives and ensure that all products are safe effective and compliant.
RESPONSIBILITIES:
Directly supervises employees in the Quality Inspection Micro Lab and
Quality Control. Carries out supervisory responsibilities in accordance with
the organizations policies and applicable laws. Responsibilities include
interviewing hiring and training employees; planning assigning and
directing work; appraising performance; rewarding and disciplining
employees; addressing complaints and resolving problems.
Builds high performance cultures and teams empowering and holding
direct reports and crossfunctional teams accountable for successful
implementation and of CAPAs continuous improvement
initiatives and other quality initiatives
Provides strategic direction and communication of the companys goals
directives and policies to subordinates creating a clear vision and
positive teamoriented environment resulting in the achievement of the
companys goals and increased profitability.
Ensure dependable and timely results from quality control including
process control and support for process changes in compliance with QSR
ISO and other regulatory requirements.
Ensure and improve product reliability through proven quality
science. Post market surveillance CAPA Complaints reduction of
nonconformity.
Oversee product quality reviews divisional management reviews and
preparation of quality reports as applicable for various forums Divisional
Board Review (DBR) Plant Operational reviews etc.
Direct the activities of the Quality Department to ensure compliance with
all appropriate regulations and standards including FDA ISO 13485
CMDR MDR and JPAL.
Ensures site compliance and readiness. Oversees external regulatory
inspections timely follow up and closure of Regulatory commitments.
Interact and coordinate activities with other departments external vendors
and customers. Influences and collaborates across stakeholder groups in
the areas of process / continuous improvements identify and implement
opportunities.
Ensure that all projects and validations are in compliance with QSR ISO
and other regulatory requirements.
Participate in evaluation of new product opportunities (introductions
enhancements obsolescence).
Maintain fiscal responsibility and budget compliance.
REQUIRED QUALIFICATIONS:
Bachelors degree in engineering Life Sciences or a related field (Masters
degree preferred).
Minimum of 5 years of experience in Quality Control or Quality Assurance in the medical device industry.
Strong knowledge of FDA regulations and other relevant medical device
standards.
Proven leadership experience with the ability to manage and motivate a team.
Strong analytical and problemsolving skills.
Excellent communication skills both written and verbal.
Experience with nonconformance management CAPA and audits.
Required Experience:
Manager
Employment Type
Full-Time
