Develop company strategy to ensure product quality is acceptable with appropriate and demonstrable data
ISO9001:2008, ISO13485:2003 and ITAR certification and compliance
Guide company in additional strategic certifications
Internal Audit Schedule
Coordinate and present Management Review Meetings in accordance with ISO requirements
Ensure review and timely action with customer issues, complaints, or rejects
Effective and timely communication with all departments with regard to product quality and customer standards
Communicate and track Customer Requirements
All customer compliance for quality reporting, certifications, and capability analysis
All customer audits
Document IQ, OQ, PQ for all equipment and "critical processes"
Optimization of customer satisfaction through improved operations
Target 100% customer lot acceptance and 100% on-time delivery
location: Union City, California
job type: Permanent
salary: $170,000 - 185,000 per year
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Develop company strategy to ensure product quality is acceptable with appropriate and demonstrable data
- ISO9001:2008, ISO13485:2003 and ITAR certification and compliance
- Guide company in additional strategic certifications
- Internal Audit Schedule
- Coordinate and present Management Review Meetings in accordance with ISO requirements
- Ensure review and timely action with customer issues, complaints, or rejects
- Effective and timely communication with all departments with regard to product quality and customer standards
- Communicate and track Customer Requirements
- All customer compliance for quality reporting, certifications, and capability analysis
- All customer audits
- Document IQ, OQ, PQ for all equipment and "critical processes"
- Optimization of customer satisfaction through improved operations
- Target 100% customer lot acceptance and 100% on-time delivery
- Implementation of productivity and quality metrics to minimize costs and enhance efficiency
- Effective planning and layout of workflow, equipment, and operations
- Recruiting, hiring, coaching, and developing staff
- Job descriptions, goals and objectives, one on one and team communications, etc.
- Developing and optimizing efficiency of workforce (direct labor as a percentage of sales)
- Budget and contingency planning
- Ensures adherence to annual budgets
- Safety and OSHA compliance in your department
- Improvement of quality by researching best practices and identifying new technology, skills, and processes
- 5S, DMAIC process, Kaizen, etc.
- Support and enhance sales process
- Recruit, train, supervise, and evaluate department staff
- Internal Auditor for ISO9001:2008. ISO13485:2003
- Must be a team player as measured by his/her peers
- Performs other related duties assigned
qualifications:
5 years of experience in Quality Management
CAPA, QIP, 5 why and strong problem-solving skills
Comfortable with training, employees, co-workers, suppliers in a positive and professional manner
Auditing certificate -ISO preferred
Supplier experience - management, monitoring, and auditing
5 or more years of experience with auditing both internal, customer and external requirements
Good knowledge of ISO 13485, ISO 9001 and other relevant specifications
Understanding of industry practices and common manufacturing
Results orientated, organized, resourceful with high initiative and problem-solving skills, resourceful with high initiative and enjoys working is a fast-paced environment
Knowledgeable skills with excel, word, PowerPoint, outlook and Solidworks (is preferred)
Experience managing and/or working within a Complaints Management system, per ISO 13485:2016 and 21 CFR 820.198
Experience investigating, writing, and reviewing deviation and nonconformance reports, CAPA, and Change Requests
Experience in SPC with Minitab
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
