Position Purpose:
The Quality Assurance Manager is responsible for managing quality assurance and quality control functions to ensure that products conform to customer specifications and requirements as well as developing quality standards, monitoring conformance to standards and identifying deficiencies. They must coordinate with manufacturing and engineering to resolve quality issues, propose corrective actions and ensure that customer’s quality issues are resolved. They must lead the organization’s efforts to comply with ISO and strive to develop and maintain a quality and continuous improvement culture.
Essential Functions and Basic Duties:
- Coordinate ISO certification and customer audits as well as regulatory inspections, follow-up reporting to agency, and coordination and implementation of corrective action plans with all departments.
- Develop and implement quality programs, meeting ISO and cGMP guidelines.
- Review and evaluate control documents, analytical results trending to assure specifications for the acceptance of components, in-process, finished products, stability, and validation content.
- Participate and support in continuous improvement initiatives as well as review and evaluate their results.
- Conduct internal audits including corrective action plan follow-up, monitoring, and results review.
- Develop and control quality documents.
- Lead corrective and preventive action teams as well as complete and track their effectiveness.
- Coordinate in process inspection, batch record review and product release.
- Facilitate training of quality assurance team.
- Maintain all quality assurance files, specifications, quality systems and certifications.
- Coordinate statistical capability studies, and assure conformity with customer specifications in accordance to ISO standards.
- Support product launches including APQP, PPAP and IQ, OQ, PQ.
- Manage customer relationships.
- Supervise and lead quality assurance team.
- Represent the company in a professional manner with customers, suppliers and co-workers.
Qualifications
Required Education/certification:
- Bachelors of Science / Bachelors of Arts in science related field or 8 years of experience in medical QA / QC setting.
- Minimum 8 years of management or supervision experience and a minimum 10 years’ quality assurance experience in plastic injection molding.
Required Experience:
- ISO experience preferred.
- IQMS experience preferred.
- Must have experience with injection mold, plastics or pharmaceutical manufacturing.
- Be able to direct 10 to 20 employees in the QC Department.
- Carry out supervisory responsibilities in accordance with our policies and applicable by law.
- Experience with Quality Improvement Tools and Techniques (i.e., Lean, Six Sigma, Statistical Process Control, and Failure Mode & Effects Analysis).
Required Knowledge:
- Knowledge of manufacturing and quality practices.
- A working knowledge of ISO 13485 and ISO 9001.
- A working knowledge of medical device manufacturing.
- A working knowledge of bio-burden measuring and maintenance levels and clean room particulate testing.
- Experience in operating within a Class 8 Clean Room.
- Understand calibrations, gage R&R, visions system for measuring products and an overall strong technical knowledge.
- Strong verbal, interpersonal, written and organizational skills.
- Strong MS Office skills.
- Strong background in Geometry & Statistics.
- SPC & analytical reporting a plus.
- PPAP/ APQP / IQ, OQ, PQ knowledge.
- Working knowledge of GD&T.
- Knowledge of CAPA.
- ASQ / CQE preferred.
- Organization structure, workflow and operating procedures.
- Knowledge of thermoplastic scientific injection molding process.
- Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their application.
Required Skills / Abilities:
- Exceptional interpersonal skills.
- Good written and oral communication skills.
- Effective problem-solving and analysis skills.
- Demonstrated leadership, project management, facilitation and problem-solving and effective verbal and written communication skills.
- An innovative and dynamic individual.
- Well organized.
- Accurate and attention to detail.
- Strong typing and computer application skills.
- Ability to assist and support others.
- Good judgment and decision making.
- Taking initiative and/or leadership on projects and strong project management skills.
- Ability to work independently and as a member of a cross-functional team.
- Effective planning/organizational skills with a demonstrated ability to multi-task and set priorities.
- Regular attendance required.
- Flexibility to work different shifts.
- Ability to travel as required (minimal).
Physical Requirements:
- Involves sitting, standing and/or walking, with frequent ability to exert up to 10 pounds of force to move objects and occasionally exert up to 20 pounds of force to move objects.
- Ability to receive detailed information through oral communication and to make discriminations in sound perceiving their nature.
- Ability to extend hands or arms in any direction. Repetitive motions, physical ability to sustain movements of the fingers, wrists, hands or arms.
- Hearing, ability to receive detailed information through oral communication and to make discriminations in sound.
- Ability to express or exchange information by means of spoken word.
- Must able to see (depth perception, near acuity and far acuity) and see colors.
- Must be able to maneuver safely around moving equipment and/or in congested manufacturing areas.
- Must be able to wear personal protective equipment including safety glasses, ear plugs, steel toed shoes, rubber gloves/boots, etc.
- Exposed to various packaging materials, raw ingredients, cleaning chemicals, lubricants, etc.
Job Type: Full-time
Pay: $105,000.00 - $140,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Relocation assistance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Relocate:
- Rancho Cucamonga, CA 91730: Relocate before starting work (Required)
Work Location: In person