RESPONSIBILITIES:

-Implement and maintain systems policy, processes and procedures for quality assurance

-Manage personnel in the Document Control and the Quality Assurance function, including inspection.

-Manage all internal and external audit related activities for the Quality function

-Assist Materials function in the supplier selection and approval process

-Implement and maintain policies and procedures for both internal and contract manufacturing processes

-Active participation in all product development Design Control teams to ensure adherence to all quality objectives and regulatory requirements.

-Handle multiple projects, establish and communicate priorities

-Work closely with all disciplines to ensure the uninterrupted supply of products

-Maintain the validation program for sterilization and biocompatibility

-10 + years in quality assurance role for a medical device or related company with a high volume of products

-Experience in creating and implementing processes and procedures

-Excellent technical writing skills, ability to write protocols and associated reports independently.

-Sound knowledge of FDA GMP regulations as well as ISO guidelines

-Demonstrated leadership position and proven track record

-Attention to detail and ability to communicate direction and range of solutions

-Experience in validation

-Excellent communication skills, both written and verbal

-Experience interfacing with engineering, marketing, regulatory and operations personnel

-Computer skills including Word and Excel

BS in Science, Engineering or equivalent.

Salary Range: $120-130,000

Holly Daniel
Executive Recruiter
Medpoint, LLC
864-244-7111 ext.104
holly.daniel@medpoint.com

RESPONSIBILITIES:

Serves as the Mount Holly facility’s Management Representative, ensuring that a quality system is established, implemented, and maintained in accordance with all applicable standards and/or regulations, which includes:

• Managing inspections by FDA
• Managing audits performed by customers and notified bodies
• Ensuring that processes needed for the quality management system are established, implemented and maintained,
• Reporting to top management on the performance of the quality management system and any need for improvement,
• Ensuring the promotion and awareness of regulatory and customer requirements throughout the organization and to the customer.
• Scheduling executive management reviews and compliance training,

Keeping current on regulatory requirements that affect the business operation.

Directing the activities of the Quality Assurance functions including:

• Overseeing in-coming inspection and acceptance activities of raw materials and components
• Overseeing in-process inspection and acceptance activities of internally-manufactured components
• Overseeing final inspection and acceptance activities of finished goods
• Working with product development to develop, maintain and review quality assurance sampling plans, inspection procedures, and test methods.
• Overseeing complaint analysis, trending, and CAPA inputs
• Monitoring the sterilization process and oversees the release of sterile finished goods
• Overseeing the documentation control function
• Overseeing the calibration function
• Ensuring that Quality Records are reviewed, are compliant with applicable regulations and standards, and are properly maintained

Responsible for the site CAPA system and it's execution. Ensures that Corrective and Preventive Actions are addressed and closed in a timely manner, escalating delinquent items if necessary.

Directs and monitors the system which manages nonconforming product to ensure compliance with regulatory requirements and internal guidelines; advises the management team of potential issues through written or oral reports.

Provides continuous improvement of Quality Assurance activities and teams by identifying and rectifying areas in need of improvement.

Establishes quality objectives for Mt. Holly facility; creates quality planning, documentation when necessary.

Acts as a liaison between Mt. Holly and other Teleflex Medical locations in terms of company Quality objectives.

Develops, reviews, and manages the documentation process to ensure compliance to regulations, including the adherence to timely product documentation deadlines. Additionally ensures that written policies and procedures are developed, revised, reviewed, approved and maintained current.

Participates in planning and implementing product and process revisions as a part of design transfers and new product development.

Performs project management work and other related job duties required to meet the goals of the organization.

Education/Professional Training

• BS in engineering, science, math or management sciences or equivalent experience.
• Training in all aspects of medical device quality systems according to 21 CFR 820, ISO-13485, and the CMDR.
• Lean/Six Sigma training preferred
• Knowledge of sterilization preferred

• Demonstrated evidence of strong leadership skills
• Minimum of 5 years of Management/Supervisory experience in the Medical Device or Pharmaceutical industry
• Demonstrated knowledge of 21 CFR Part 803, 21 CFR Part 820, ISO-13485, Canadian Medical Device Regulation, and the Medical Device Directive, with the ability to explain these regulations and standards to and train those not as familiar.
• Proven understanding of CAPA systems, training, and document control requirements.
  

Holly Daniel
Executive Recruiter
Medpoint, LLC
864-244-7111 ext.104
holly.daniel@medpoint.com

Performs other related duties as required.

JOB REQUIREMENTS:

- Education : Bachelor’s degree or equivalent experience

- Experience : 5-10 years min in a similar Medical Manufacturing environment

Holly Daniel
Executive Recruiter
Medpoint, LLC
864-244-7111 ext.104
holly.daniel@medpoint.com

POSITION RESPONSIBILITIES:

• Lead Continuous Process Improvement Teams chartered to achieve plant quality objectives.
• Initiate root cause analysis and corrective action efforts when plant
  quality objectives are not met.
• Review progress to plant quality objectives with the Plant Quality
  Manager.
• Provide quality assurance engineering expertise as a member of the New Product Development team to assure compliance to specifications.
• Analyze quality assurance data and initiate root cause and corrective
  action efforts to eliminate assignable cause affecting product quality.
• Certify manufacturing processes using quality assurance tools.
• Charter Material Review Board.
• Lead continual improvement of suppliers via assessment audits.
• Conduct supplier quality meetings.
• Develop processes and procedures in accordance with ISO9000 or QS9000 based quality system elements.
• Drive adequacy and conformance of processes and procedures through the internal audit process and the corrective action process.
• Participate in Plant Quality Audits
• Verify effectiveness of implemented corrective actions prior to
  standardization.
• Complete assigned projects related to the continual improvement of the
  Azusa Manufacturing Plant Quality Management System.

• BS degree in engineering or other technical discipline.
• Knowledge of world class manufacturing principles.
• Excellent problem-solving skills and team orientation. Strong
  interpersonal, team-building, and negotiating skills. Ability to recognize
  opportunities for improvement and implement changes.
• 3 to 5 years leadership experience as a quality engineer, supervisor or
  manager in a high volume manufacturing organization.
• Working knowledge of SPC, Pareto analysis, Gage R&R, Control Plans, FMEA, DOE, DFM
• Experience in customer/supply management.
• Experience with inspection methods, data analysis and design review.

• MBA or MS degree in related field
• Experience with implementation of Total Quality Management (TQM)
• Experience in supplier management
• 5+ years experience in a similar position
• ASQ certification in one or more areas (CQE, CMI, CQM, CRE,etc.).
• Bilingual English/Spanish

Please submit resumes to:
Ahmad Ranjbari via inter-company mail; fax
Fax# (626) 812-3448
or e-mail (aranjbari@rainbird.com)

A. Ranjbari
Azusa Plant Quality Manager
1000 W. Sierra Madre Ave.
Azusa, CA 91702
Tel# (626) 812-3452
Fax# (626) 812-3448
http://www.rainbird.com