Job Description
JOB FUNCTIONS
- Manages Quality Assurance systems functions at the site level
- Create, manage and maintain sales / operational excellence performance metrics
- Assists staff in audit follow-up procedures for the purpose of instruction, feedback, and continuing staff development
- Participates in Strategic Planning for the department
- Oversees the management of all quality systems for all laboratory sites
- Acts as liaison to customer auditors and regulatory inspectors.
- Hosts and coordinates inspections involving the company as necessary with regulatory agents on-site
- Acts as a regulatory resource, support, and coordinator for SGS customers and staff
- Prepares responses to audit reports from clients and regulatory agencies
- As a part of the leadership team, conducts cross-departmental workshop training
- Performs in-life audits of Good Laboratory Practice (GLP) studies
- Performs final audits of Good Laboratory Practice (GLP) reports
- Acts as the site Management Representative
- Performs internal audits of departments, data, systems, and facilities. Reports findings to management. Organizes and plans follow-up inspections as part of corrective action processes
- Performs audits of vendors and subcontractors as mandated by executive management
- Oversee maintenance of SGS Operations Manual. Maintains file of all historical procedures and protocols, writes SOPs pertaining directly to quality functions, reviews new or revised SOPs
- Leads compliance-driven, competitive advantage, and quality improvement projects
Qualifications
EDUCATION AND EXPERIENCE
- or in relevant area of study
- 7+ years of experience in a testing laboratory setting, preferably with Electronic / Electrical products
- Must have a solid grasp of ISO 17025 / 17065, 5S, Net Promotor Score, and other process / quality related areas of expertise
KNOWLEDGE / SKILLS / ABILITIES
- Must be able to think critically; problem-solving skills essential
- Knowledge of and familiarity with word processing and database software required
- Advanced language proficiency (fundamentals of grammar and syntax) required
- Solid organizational skills are required; must be able to prioritize multiple tasks
- Must be able to obtain and assess objective evidence fairly
- Excellent language and communication skills are required. Must be able to clearly communicate priorities and responsibilities daily.
Must be able to convey complex ideas in easily understandable terms to both internal staff and outside auditors
- Good listening skills are essential. Must be able to elicit precise information from persons with varying professional expertise
- Solid leadership skills are essential. Must be able to lead both by example and through direct authority. Must be able to unite staff under common goals pertaining to quality.
Must be able to build consensus across departments. Must be able to deliver criticism in a constructive, diplomatic manner
- Must be able to with persons from diverse backgrounds
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