Quality Systems Specialist Engineer

Quality Systems Specialist Engineer (Medical Devices Manufacturing Company)Quality Systems Specialist Engineer (Medical Devices Manufacturing Company)

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Name: Job Description - Quality Systems Specialist Engineer

(EXP IN MEDICAL DEVICES MANUFACTURING COMPANY PREFERRED)

SECTION 1: JOB SUMMARY*

This position will have responsibilities in coordinating the change control documentation and approval process, provide quality support for technology transfer and improvement of existing processes. Conduct investigations, collects data, analyzes trends and prepares reports for assigned quality processes. Role will have thorough understanding of process criteria and regulations and business impact of decisions and actions. Assesses current quality systems and recommends improvements to enhance quality and improve quality system elements assigned to support. Prepares for and facilitates audits and inspections. Monitors trends, identifies issues, recommend, and implement appropriate actions. Assists in the development, implementation, and review of standard operating procedures for interactions with internal and external stakeholders.

SECTION 2: DUTIES & RESPONSIBILITIES* In accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, this position:

o Responsible for assigned key processes such as: CAPA/NC coordination and monitoring , Training SME, and Quality Systems SME; as Quality Systems Specialist Engineer main activities are to support and coordinate the assigned Quality elements needs for the site, facilitating and providing guidance on assigned areas.

o Responsible for reporting metrics related for areas of support to appropriate review boards such as Management review, Data review board, periodic metrics reporting, etc.

o Manage, maintain, improve, and standardize processes under role responsibility to support ensuring compliance with FDA regulations, ISO Standards and all applicable regulatory authorities' requirements.

o Implement/modify quality systems to address changing Regulations or industry standard, providing regulatory interpretation and guidance where required.

o Follow all company safety policies and other safety precautions within the work area. Set standards for safe behavior. Recognize and reward safe behavior in others.

o Coordinate and participate in special projects as assigned

o Act as backup support for Quality System roles as part of the Quality Systems team.

o Responsible for communicating business related issues or opportunities to next management level o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

o For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

o Performs other duties assigned as needed

SECTION 3: EXPERIENCE AND EDUCATION*

• University/Bachelor Degree of Science or Engineering field is required.

• This position requires from 3+ years of experience in medical device manufacturing or related industry experience is required.

• Demonstrated knowledge of quality system principles, practices, and processes such as CAPA, Change Design, Training, Management Review, Data Analysis is required.

• Knowledge of specific business software and software applications such as Windchill, EtQ, Compliance Wire, Minitab, etc. is preferable.

• Ability to communicate effectively with a diverse stakeholder.
• Ability to work cooperatively with coworkers and the diverse teams.

• Ability to perform duties in accordance with policies and procedures and in to comply regulatory requirements.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Prior experience in ISO 13485 and or QSR 820 FDA regulated environment.

• Excellent interpersonal relations and communication skills.

• Skilled at preparing executive briefings and broad communications.

• Strong oral and written communications skills with ability to speak to broad, nontechnical audiences/ external personnel.

• Skilled at preparing executive briefings and broad communications for written or oral presentation to members, notified bodies, and regulatory entities.

• Skilled Microsoft (Excel, Power Point, SharePoint) knowledge.

• Ability to make solid decisions that will effectively support the business and company policies.

• Ability to work in fast paced environment and rapidly shifting priorities with business and financial acumen.

• ASQ Certification(s) is preferable.

• Highest Ethical & Integrity Standard No

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesIT Services and IT Consulting

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