Quality Engineer - Spectra Medical Devices LLC.

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Spectra Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, were also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

JOB TITLE: Quality Engineer

REPORTS TO: Director, Quality & Regulatory

FLSA CLASSIFICATION: Exempt

POSITION SUMMARY:

The desired candidate will have prior experience working as a Quality Engineer, preferably working in a medical device company. Specific experience and responsibilities will include, but not limited to, providing Quality and Compliance related support to the manufacture and distribution of medical devices in accordance with applicable medical standards and regulations (ISO 13485, 21 CFR 820, etc.)

ESSENTIAL FUNCTIONS / MAJOR RESPONSIBILITIES:

• Provide technical support for review and approval of customer complaint investigations
• Facilitate Non conformances and MRB activities
• Facilitate the execution of Risk Management activities
• Identify statistically based sampling plans for inspections and validations
• Support validations for new and existing products, processes and equipment
• Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
• Participate in FDA inspections, ISO Registration and surveillance audits and customer audits
• Identify and implement opportunities for continuous improvement
• Interact and coordinate activities with other departments, external vendors and customers
• Assist or lead in the identification and implementation of CAPA
• Aid in the implementation SPC control system with Manufacturing and Quality Control
• Support internal quality system audits
• Provide support necessary for supplier controls, including but not limited to supplier audits
• Participate in Post-Market Surveillance (PMS) activities as required
• Collect and report metrics and data as required
• Perform other Quality System related duties as required

MINIMUM REQUIREMENTS: 

• Bachelor's degree, preferably in Engineering, Science (Biology, Chemistry, Physics, etc.) or Math (Statistics)
• 1-3 yrs Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA regulated environment

• Knowledge of statistical sampling and analysis
• Knowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standards
• Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T)
• Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e, Six Sigma, Lean manufacturing, etc.).
• Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) would be a plus
• Excellent organizational, verbal, written communication and problem-solving skills
• Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner
• Ability to work in a fast-paced environment and to meet tight deadlines
• Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
• Ability to problem solve, and multi-task with strong attention to detail
• Proficient in MS Office Suite, Visio and Project
• Experience working in a start-up environment, helpful

PHYSICAL DEMANDS & ADA STATEMENT:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or HR to understand the Work Conditions and Physical requirements that may be specific to your role.

An Equal Opportunity Employer: Spectra believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.