Quality Operations Manager
5 maanden geleden
Develops, implements and maintains quality control requirements and processes.
- Communicates and enforces business objectives, policies and procedures to the department.
- Recommends revisions to standard operating procedures and observes employees to ensures compliance with business.
- Manages the proper installation and routine maintenance of processing equipment.
- Establishes systems to ensure quality control compliance. Encourages employee’s leadership, motivates through regulatory compliance, rewards, job enrichment, environmental, health and safety compliance and challenging assignments.
- Supports and enforces employee’s training programs, team development and integration.
- Acts as change agent in the Continuous Improvement process by fostering team formation and providing team members the necessary tools to be successful. Identifies, develops, and participates in continuous improvement projects and programs to recommend work simplification, eliminate non-value-added activities, and cost reduction.
- Follows, observes and promotes all regulatory requirements compliance applicable to the plant (QSR, ISO, FDA) rules, procedures, and internal policies, and directs training related activities to ensure compliance with procedures established by the Company, and ensures these are also followed and observed by personnel supervised.
- Addressing non-conformities within production and taking care of internal escalations.
- Advising, reviewing and (approving) changes in production processes, in line with the applicable procedures
- Analyzing data on rejects within the production process for continuous improvement and reducing or eliminating sources of variation within the production process
**Qualifications**:
- Bachelor’s Degree or equivalent.
- 6-8 years of experience in Quality Engineering or Quality Assurance functions within the Pharmaceutical or Medical Device Industry is required.
- 2-4 years in supervisory experience.
- Experience dealing with applicable Health Authority inspections.
- Good written and oral English communication skills.
- Ability to select, manage and direct a team as applicable.
- Ability to respond to common inquiries, regulatory agencies, or members of the business community.
- Statistical skills and manufacturing process understanding.
- Ability to lead a team through a root cause analysis problem.
- Ability to effectively present information to top management. public groups. and/or boards of directors.
- Ability to stand firm while being open to new approaches. Engages in constructive conflict.
- High tolerance for ambiguity in a complex environment. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to build partnerships both internally and externally. Ability to effectively interface with governmental and independent auditors.
- Ability to use PC's and associated Microsoft software.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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