Department: Quality System & Quality Assurance
Reports To: Manager, Quality Systems & Quality Assurance
SUMMARY
Perform internal audits of the company Quality System and processes, perform external supplier audits of their quality systems and processes, follow-up on corrective action progress and/or effectiveness for audit non-conformances, prepare internal and external audit schedules, serve as an internal compliance/regulation expert and communicate applicable regulation changes to the organization.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The duties and responsibilities of this position include the following, although other duties may be assigned.
Responsible for execution of internal audits. Plan audit, execute and prepare audit report. Formally document findings. Work with the departments audited to resolve compliance issues, provide recommendation, communication on status of action resolution and bringing to management issues that require attention tracking corrective actions. Maintain data base, files generated from each audit.
Responsible for on-site audit of supplier quality systems. Plan audit, execute and prepare audit report. Formally document findings. Maintain data base, files generated from each audit. Perform necessary follow-up which include communicating with auditee(s) on status of action resolution.
Maintains up to the date the company training program. This includes helping other departments in creating training matrices for new position or updating as roles change. Prepare training materials for different sections of the QSR, as required.
Provides internal communication regarding compliance issues and applicable regulation changes. Aids in the creation of gap analysis to any new/changed regulations.
Support FDA, FDB, Government inspections, and International Regulatory inspections, preparations and corrective actions as needed.
Collaborate with different members of the QA/RA department working in special projects. Perform additional assignments as directed by Supervisor. Assist in maintaining various quality systems and programs, as needed.
We are an Equal Opportunity Employer.
Excellent Salary and Benefits.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND/OR EXPERIENCE
Bachelors Degree in Science, or other related technical discipline.
At least 5 years of experience in an FDA medical device regulated industry.
At least 3 years of experience auditing to 21 CFR 820 Quality System Regulations or ISO standards.
Biotechnology industry experience a plus.
KNOWLEDGE AND SKILLS / ABILITIES
Excellent knowledge of QSR/GMP/ISO regulations as related to medical device manufacture. Strong knowledge of statistics and sampling plans.
Working knowledge of biologic regulations, pharmaceutical regulations, and GCPs a plus.
Strong Verbal and Written communication skills (English), as reports are highly visible.
Strong interpersonal skills, as this individual works on quality/compliance issues with all the different departments. Strong problem solving skills.
Prepare audit agendas/plans, final audit reports/findings and distribute, and lead and train audit teams, as necessary. Work on quality/compliance issues of moderate scope where analysis of data requires evaluation of identifiable factors.
Requires strong computer skills, Microsoft Office Applications (Access, Excel, Power Point and Word).
Must be detailed oriented, possess excellent time management skills, be well organized, a self starter and display a professional demeanor wit a high focus on compliance and responsibilities.
Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date; ability to closely monitor and communicate progress to Management.
Must be able to work independently with minimal supervision.
LANGUAGE SKILLS
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively before groups of customers or employees of organization.
MATHEMATICAL SKILLS
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS
ISO 13485 lead auditor certification preferred.
ASQ CQA or ISO lead auditor certi |
