The Quality Manager is responsible for the Quality Systems and Inspection.
JOB 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 AND SKILLS:REQUIRED - 10 to 15 years of progressive operational and management experience
- Relevant industry experience
- Proven track record in the management of quality assurance
DESIRED QUALIFICATIONS AND SKILLS: - 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
REQUIRED - 10 to 15 years of progressive operational and management experience
- Relevant industry experience
- Proven track record in the management of quality assurance
- Certificate of ISO 13485 or AS9100 Lead Auditor
Benefits offered:
- Full medical, dental and vision.
- 401K with company match
- PTO / Holiday pay
Pay Details: $150,000.00 to $170,000.00 per year
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy
The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance
Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.