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Change Control Specialist 1st Shift (8A-4:30P, M-F)

Summary

**Title:** Change Control Specialist 1st Shift (8A-4:30P, M-F)

**ID:** 2883

**Department:** Quality

**Location:** Buffalo, NY

Description

Job Summary

Facilitates the Engineering Change Order (ECO) and QMS Change Order (CO) processes owned by the Quality Department. Ensures that all necessary requirements are completed/ reviewed by the appropriate stakeholders prior to implementation of ECOs. Ensures that the ECO moves through the stages in a timely fashion.

Essential Job Functions

1. Facilitates all new and revised medical device product and component specifications via ECO. Coordinates required actions from required departments prior to the implementation of any ECO’s.

2. Initiate ECOs and QMS COs, move COs through the workflow, and ensure proper approvals are received within Oracle.

3. Identifies deviations to current procedures, drawings, specifications, and work instructions and creates/routes Deviations, as needed.

4. Manages Deviation Log. Move approved revisions into Master Device Records (active) and old revisions to Obsolete. Ensure all revisions and item/document statuses are correct within Oracle.

5. Send artwork proofs and ECRs (when required) to customers through customer service or product manager.

6. Manage controlled copies of procedures and other controlled documents.

7. Update drawings for typos and changes that do not require an Engineer.

8. Build/update Specs and IIR’s as needed. Maintain current and accurate specification files.

9. Provides internal product detail support for all departments. Co-ordinate resolution of specific product specification record discrepancies.

10. Manages assigned projects as needed.

11. Make changes to WI, Forms, or SOPs as requested.

12. Send document reviews for the required approvals at the designated intervals and ensure their timely completion.

Requirements

• Minimum Associate degree, Bachelor’s degree preferred. Experience with Microsoft Office and Oracle preferred.

Knowledge, Skills, and Abilities

• Excellent project management skills

• Strong leadership abilities

• Able to coordinate numerous, diverse, detailed activities concurrently

• Excellent communication skills; both written and verbal

• Self-motivated

• Detail oriented

• Good math skills

• Experience with Microsoft Office & Oracle preferred

• Able to work well independently, as well as in a team setting

Other Information

•Participate in the reduction of risk and injury in the workplace by completing required job safety training, identifying workplace risks. Compliance to Safety Standards and Policy: Immediately informing manager, supervisor, and/or Team Leader of unsafe conditions, practices, incidents, and injuries.”

Great benefits offered including medical, dental, 401K, education assistance, and more!

_Nissha Medical Technologies is committed to fair, competitive, and market-informed pay for our employees. The pay range for this position is $20-30/hour(USD).The successful candidate’s particular combination of knowledge, skills, and experience will inform their specific compensation._

Why choose Nissha to build your career?

At Nissha, you can be assured that you will be part of a dynamic, diverse team that is committed to bringing the best versions of ourselves each and every day. We recently received the “General Excellence” manufacturing award from Buffalo Business First, which highlights our dedication to quality, innovation, and sustainability. This recognition celebrates the hard work of our team in producing high-quality medical devices that meet industry standards and enhance patient care. If you are looking for meaningful work that motivates and inspires, you’ve come to the right place!

What we offer that you’ll love…

+ Company Culture: At Nissha, we pride ourselves on cultivating an atmosphere of teamwork where all associates feel heard and valued. We may not all think the same, and we wouldn’t have it any other way.

+ Diversity & Inclusion: We are committed to equity, racial justice, and equal opportunity for all.

+ Training and Development opportunities: Because we foster a culture of continuing education. Let’s learn and grow together!

+ Team Building, Connection, and Relationships: We support each other, celebrate our achievements and milestones together, and have FUN.

+ Retirement: We know you want to retire comfortably and we’re here to help! Nissha offers a 401(k) Retirement Plan with an attractive employer contribution.

+ Time Away from Work: Whether it is vacation or sick leave, we all need time to recharge. Paid time off is an essential associate benefit and a pillar of self-care.

+ Engagement Activities: Recognition isn’t just a once-a-year occurrence at Nissha. We celebrate our team members year-round with summer picnics, holiday parties, and employee spotlight events, just to name a few.

+ Commitment to Wellness: We offer various opportunities to learn about your health, be healthier, and get rewarded for your healthy lifestyle by offering reduced medical premiums.

AND SO MUCH MORE!

_Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, gender expression,national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities._