Quality Assurance Manager in Suffern, NY at Tecomet

Date Posted: 11/7/2019

Job Snapshot

Job Description


JOB SUMMARY:

The position provides overall quality leadership and direction to meet customer quality requirements, create, monitor and improve quality programs, reduce quality costs and maintain compliance within FDA and ISO regulations for the Hillburn NY facility.  This is accomplished by maintaining Tecomet’ principles of Safety, Quality, Customer Satisfaction and Innovation.

ESSENTIAL FUNCTIONS:

•        Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs.

•        Serve as the site Management Representative for all Quality System audits and inspections

•        Participate in Material Review Board process.

•        Lead internal & external audits and manage supplier quality programs.

•        Develop global Quality and Manufacturing standard operating procedures and related improvement plans.

•        Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans.

•        Write, review and approve validation reports, SOP’s and other technical documentation

•        Manage the CAPA program.

•        Maintain a culture where safety, quality, schedule and cost are the main focal points with a continuous improvement mentality

•        Records retention/archive management.

•        Investigate and resolve complaint investigations and reporting.

•        Facilitate any necessary quality or regulatory training internally or externally.

•        Project a positive and professional image of the company and of management to employees at all levels.

•        Additional functions and requirements may be assigned by manager as deemed appropriate.

KNOWLEDGE, SKILLS AND ABILITIES:

•        Knowledge of medical device, FDA & ISO 13485.

•        Strong knowledge in manufacturing operations.

•        Lean manufacturing experience.

•        Highly organized and self-motivated to complete projects on time; leader to execute quality improvement initiatives.  

•        Ability to communicate professionally to common inquiries or complaints from customers, or regulatory agencies.

•        Ability to define problems, collect data, establish facts, and interpret technical instructions.

•        Ability to apply advanced mathematical concepts and apply mathematical operations to determine such tasks as test reliability and validity, correlation techniques and factor analysis.

•        Ability to effectively present information and respond to questions from teammates, direct reports, management, and internal and external customers.

•        Proficient in Microsoft Office Suite.

•        Meet goals and objectives set for department and company.

EDUCATION AND WORK EXPERIENCE:

•        Minimum Bachelor of Science degree in an Engineering, Science or Regulatory-related field.

•        Minimum two years of leadership experience in a quality position in a regulated industry, preferably medical device

•        Minimum 3 years quality engineering experience in a manufacturing environment.

•        ISO/FDA lead auditor certification preferred

•        ASQ CQE and/or CQA, CQM certification preferred.

PHYSICAL AND ENVIRONMENTAL DEMANDS:

•        Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.

•        Light physical activity performing non-strenuous daily activities of a primarily administrative nature.

•        Ability to maneuver throughout the facility/facilities as needed.

•        Manual dexterity sufficient to reach/handle items and work with fingers.

•        Ability to wear proper PPE.


Tecomet is an Equal Opportunity Employer M/W/VET/DISABLE

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