CAPA Systems Engineer, Senior Staff

Job Description:

SUMMARY: Leads and performs planned and unplanned Internal audits to verify compliance to the Quality Manual and applicable documents. Recommends and lead improvement to quality systems based on assessments performed, external feedback (i.e. customer audits) and quality systems performance as periodically reviewed (i.e. Management Review). Provides compliance guidance to the organization as required including guidance to lower level personnel. Exercises judgment within defined procedures and practices to determine appropriate action. Participates in decisions on scope of work and length of tasks. Writes, reviews, documents, and implements requirements.  Provides and develops solutions to problems of limited scope. Supports Quality Systems such as but not limited to: Training Management, CAPA and Compliant and Supplier Management

ESSENTIAL DUTIES AND RESPONSABILITIES include the following. Other duties may be assigned.

• Plan, lead and participates quality system internal audits.

• Coordinate and host customer inspections (desktop, remote or on-site).

• Assigns actions or Corrective actions for deficiencies as needed and required.

• Assigns classifications and documents audit results in written audit reports.

• Maintains files containing reports of audits and corrective action responses.

• Reviews audit responses and assists with required training in response to audit findings and other GMP/QSR/ISO related issues as needed.

• Performs cross-site audits as requested by management.

• Provides direction and guidance to auditors in training.

• Responsible to prepare and present Management Review.

• Responsible for following all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.

• Review Quality System performance through periodically (i.e. Management Review, ORB meeting, etc) and lead improvements.

SUPERVISORY RESPONSIBILITIES: Have supervisory responsibilities: Yes                  

Leadership: Quality Systems Engineer

Supervises: Quality Assurance Technician

Supervision: General Direction: receive very general guidance with respect to overall objectives; work is usually quite independent of others; operate within division or department policy guidelines using independent judgment in achieving assigned objectives.

EDUCATION and/or EXPERIENCE:

• Bachelor degree in engineering or business discipline; also 6-7 years of related experience (preferably within the medical device industry).

• Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of relates specialties.

• Experience and knowledge in Root cause Investigation and CAPA in the Medical Device Industry, MDSAP and EU MDR would be important assets.

• ISO 13485 Lead auditor is a must.

OTHER SKILLS and ABILITIES:

• Advance written and oral English communication skills. 

• Ability to select, manage and direct a team during an audit. 

• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. 

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 

• Ability to use PC's and associated software. 

• Ability to effectively interface with governmental and independent auditors.

• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.

• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

• Ability to write speeches and articles for publication that conforms to prescribed style and format.

• Ability to effectively present information to top management, public groups, and/or boards of directors.

• Ability to define problems, collects data, establishes facts, and draw valid conclusions.

• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

MANUAL DEXTERITY: Manual dexterity sufficient to reach/handle items and work with the fingers.

WORK SCHEDULE/HOURS: Monday – Friday 8:00 am - 5:00 pm.

TRAVEL: Minimal

ENVIRONMENTAL WORKING CONDITIONS: Well-lighted, heated and/or air-conditioned indoor office setting with adequate ventilation.

PHYSICAL DEMANDS

Other physical working conditions: Moderate noise

PHYSICAL ACTIVITY LEVEL: Sedentary physical activity performing non-strenuous daily activities of an administrative nature.

COMMENTS:  This position description is an outline of the major recurring responsibilities of the job.  It is not intended to be all‑inclusive of the work to be performed.  The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.