Sr. Document Control Specialist

Job Description

Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Document Control Specialist for a 12 Month Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Position Description

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimum supervision. Under minimal supervision administer Device Master Record (DMR) and Design History Files (DHF) in accordance with corporate documentation procedures and FDA Good Manufacturing Practices (GMP).

Three days on site (Mon, Tues, Wed) two days remote (Thur, Fri)

Primary roles/responsibilities:

Will administer the DMR, Specifications, Change Orders, Parts and Bills of Material, through the release and distribution processes in accordance with corporate and department documentation procedures and guidelines.

Will interface with document creators and reviewers to evaluate and judge accuracy and completeness of DMR documentation and change paper within corporate procedure and GMP requirements.

Will collaborate with other departments (e.g., design engineering, purchasing, quality, product line support, test engineering, and manufacturing engineering) to ensure necessary requirements will be met for documentation, parts and Bills of Material.

Will provide training and support to team members and stakeholders on PLM and ERP tools.

Will administer current and historical DMR files in accordance with defined filing standards, record retention policies and GMP.

Will support configuration Management process improvement projects and Kaizens.

Will help establish, create, and maintain document center guidelines and procedures.

Will support and enforce data governance policies and procedures to ensure data accuracy, consistency, and compliance with regulations.

May execute process and technology projects to add/correct/update/maintain required attributes for production, regulatory (UDI, ACE, PMA, MDD etc.), and to product master data tables to support Order to Cash process.

Qualifications/Experience:

Bachelor's degree is required in Supply Chain, Manufacturing or Information Management

3+ years experience in configuration control, or 5 years' experience with a combination of a minimum of 3 years' configuration control experience and equivalent production experience

Familiarity with MS Office required, Advanced Excel skills required.

Detail oriented. Customer Service oriented.

Must be able to multi-task and prioritize.

Strong communication skills and organizational skills are essential.

Experience in Agile PLM and with Change Control highly desired. Company Description

Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.

Benefits:

401(k) matching

Comprehensive dental, vision, and health insurance

Flexible schedule options

Health savings account

Life insurance

Paid time off

Professional development assistance

Employee assistance and discount programs

Referral program

Retirement plan

Tuition reimbursement

iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential.

Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!

Contact us today to learn more:

*** Grand Rapids, Michigan:

*** Tampa, Florida:

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Hybrid remote