Quality Assurance Director- Healthcare jobs in Santa Maria, CA

Imagine working for one of the leading contract manufacturers in the world. Trelleborg Healthcare and Medical is located 30 miles from California’s pristine Central Coast. As a premier manufacturer for life-saving medical components, Trelleborg Healthcare and Medical is a forward thinking company. We have been active in our lean manufacturing journey for many years and are advancing towards making our business a showcase of excellence in the medical industry.

Seize this rare opportunity to be part of a healthcare and medical business unit that has been in business for over 100 years, all while enjoying the benefits of living in one of California’s most desired locations!

As a valued Trelleborg team member, you will enjoy:

• Greater opportunity for impact;
• Competitive compensation;
• Outstanding benefits package: Health, Dental, Vision, STD, LTD, Life, 401k;
• Generous paid time off;
• Bonus potential

Trelleborg Healthcare and Medical is seeking a Quality Assurance Supervisor. Responsible for the coordination of the ISO program, quality system, quality system training, internal audits, customer audits, the document control process, supervision of document control and quality personnel, Lead lean initiatives to improve the QS for the company, and coaches/mentor employees on QS compliance.

Quality Assurance Supervisor Tasks and Responciablities:

• Work with functional managers to assure that business work processes are effective, efficient and meet ISO, regulatory and customer requirements
• Oversee creation and maintenance of processes for documentation and record control systems requirements
• Responsible for ensuring the Standard Operating Procedures (SOPs) meet the ISO standard and FDA QSR requirements.
• Oversees preparation of the Monthly & Quarterly reports for management review.
• Oversees preparation of the QS Management review presentation, and documents meetings.
• Presents metrics for Management Review
• Provides training to cross-functional personnel regrading Quality System and Document/Record Control requirements.
• Implements continuous improvements to maintain effective and efficient program.
• Ensures control of company documents and records, adheres to ISO, FDA, and etc. requirements
• Implements, validates and maintains Document Control System.
• Coaches and mentors staff.
• Shares leadership duties for the Corrective and Preventive Action (CAPA) system, nonconformance (NC) system, complaint-handling system, training program. Manages NC and CAPA tasks related to Document and Record Control.
• Adheres to the company’s Quality System, writes and approves Quality System documents, initiates and leads projects to improve the system.
• Provides support for internal, customer, and external audits or other external quality requests

Required:

• High School Diploma or equivalent
• 5 years progressive Quality experience in manufacturing, preferably in the medical device industry.

Desired:

• 4 year degree
• Leadership/Supervisory experience
• ISO13485:2016 and/or ISO9001:2015 Auditor Certification
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable).

Compensation package range: $65,000-$80,000

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