S970
Located in Bellingham, WA
Pay: $27.00-$30.00/hr
Job Full Description
Are you a detail-oriented professional with a passion for quality and compliance? Join our team as a Quality Systems Management Coordinator and play a crucial role in ensuring our products meet the highest standards and regulations.
Compensation:
- Pay: $27.00 - $30.00 per hour
- Expected hours: 40 per week
About the Role: As a Quality Systems Management Coordinator, you will be responsible for sustaining and improving our Quality Management System. Your expertise will help us create, implement, and maintain work instructions based on process flows, ensuring our products consistently meet quality standards.
Key Responsibilities:
- Oversee and maintain our Quality Management System, ensuring full compliance with ISO standards (ISO 13485).
- Develop and maintain quality documentation, including SOPs and work instructions.
- Manage the Corrective/Preventive Actions process, driving solutions to closure and addressing audit findings and customer issues.
- Schedule, coordinate, and conduct both internal and external audits.
- Maintain Supplier and Customer monthly Scorecards, sending out monthly reports to suppliers on the Preferred Supplier list.
- Collaborate with cross-functional teams to enhance and implement quality systems and processes.
- Engage with customers and customer service to resolve quality issues, including site visits and communication as required.
- Manage customer returns; lead investigations into non-conformances and customer complaints, identifying root causes and implementing corrective actions.
- Provide training to employees on quality systems, procedures, and best practices.
- Stay up to date with changes to the ISO13485 standard and industry best practices.
- Support the development and implementation of continuous improvement initiatives.
- Perform other duties as assigned.
Education/Experience:
- Bachelor’s degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline, and at least one year of experience in regulatory affairs or quality management systems relating to medical devices – OR – four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
- Experience in conducting ISO or regulatory audits.
- Proficient in technical and report writing, strong verbal and presentation skills, able to effectively liaise with all levels of facility personnel, customers, and suppliers.
- Strong knowledge of quality management principles, practices, and methodologies.
- Familiarity with FDA and EU MDR regulations is a plus.
- Experience with an ERP system (SAP) is a plus.
- Ability to conduct root cause analysis, analyze data, identify trends, and make data-driven decisions.
- Initiative, independence, and the ability to work effectively with minimal supervision.
- Proficient in project management techniques, including planning, organizing, and monitoring project progress.
Benefits:
- 401(k) with matching
- Dental Insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Tuition reimbursement
- Vision insurance
Join us and be part of a team dedicated to excellence in quality and compliance. Apply today to make a difference!
Benefits Available to Eligible Express Associates:
- Dental Plan
- Holiday Pay (6 observed days)
- 401(K) Retirement Savings Plan
- Vision/Eyewear Plan
- Life Insurance
- Prescription Drug Reimbursement
- Short-Term Disability
- Referral Bonus of $200.00 for every successful referral
- Weekly Pay
- Direct Deposit
- Visa Cash Card
We take walk-in interviews Monday-Friday from 7:00 AM-5:00 PM! Or you can call or text us at 360.734.2457 for an immediate interview!
Express offers a $200.00 CASH referral bonus for every successful referral! Ask us for more details!
For confidential consideration, we offer several ways to apply:
-Call or text our office at 360-734-2457 for an immediate phone interview.
-Complete an online application on our website: www.expresspros.com/apply
-Email your resume to: Shannon.Jacoby@Expresspros.com
-Come by our office and talk to one of our Employment Specialists: 4164 Meridian Street Ste 200 Bellingham, WA 98226
About Express Employment Professionals:
When you choose Express Employment Professionals for your employment search, you gain access to a network of top local companies and the support of our experience in hiring professionals who specialize in recruiting. Your education, skills, and experience are matched with the short-term, contract, and full-time positions our client companies have hired Express to recruit for. This is a FREE service for all job seekers!! Express has a wide range of jobs that meet employment goals including Administrative, Professional, Skilled Trades, and Commercial positions.
Our Professional Division is always recruiting for:
· Bookkeeper
· Full Charge Bookkeeper
· Accounts Payable
· Accounts Receivable
· Collections
· Bank Teller
· Accounting Technician
· Marketing Manager
· Buyer
· Inside Sales Account Manager
· Operations Coordinator
· Human Resources
· Recruiter
· Human Resources Assistant
· Staff Accountant
· Payroll
· Billing
· Controller
· Financial Analyst
For a complete list of all open positions:
Visit https://www.expresspros.com/bellinghamwa
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Bellingham, WA
1466
4164 Meridian Street
Suite 200
Bellingham, WA 98226
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