Senior Quality Coordinator

ABOUT US

Orchid Orthopedic Solutions is world leading Medical Device Contract Design and Manufacturing company that offers a comprehensive portfolio of services for implants and instruments with significant experience in the joint reconstruction, spine, trauma, dental and sports medicine markets. Established in 2005 with a roll-up of best-in-class medical device suppliers with 120 employees. This site specializes primarily in Swiss style turning (straight flute cutting tools and bone & plate screws). We are also FDA registered and ISO 13485 certified. A career with Orchid provides training and growth opportunities, great benefits, including quarterly bonuses, insurance, 401(k) with company match, paid time off and employee engagement events. For more information, please visit www.orchid-ortho.com.

SHIFT

A BRIEF OVERVIEW
The Senior Quality Coordinator maintains quality systems, ensures training is performed and recorded as required, and serves as a resource to the Quality and Regulatory functional groups at Orchid Santa Ana.

WHAT YOU WILL DO

• Manages the Corrective and Preventive Actions (CAPA) System
• Coordinates internal audits of the quality system
• Provides quality system training to new employees and conducts ongoing refresher training for existing employees
• Coordinates the nonconformance process and runs Material Review Board meetings
• Supports Quality and Engineering staff with activities such as product quarantine
• Manages the calibration process
• Monitors site quality metrics
• Serves as local process owner for MQ1, EtQ, and Compliance Wire
• Supports the Management Review process to ensure ongoing compliance and effectiveness of the Orchid QMS which may require preparing meeting minutes/PowerPoint and tracking action items
• Supports Quality and Engineering staff with ballooning new or revised drawings
• Supports creating/updating inspection checklists
• Manages the intake and processing of complaints.

• Processes and reviews document creation/change requests
• Assists document owners with writing, editing and training of new and revised procedures
• Assists with coordinating, tracking, and recording training
• Tracks and trends quality metrics
• Participates in internal and/or external Inspections, as required
• Verifies employee training is current and complete
• Assists with Document Control activities (including, but not limited to: closing jobs in Enterprise Resource Planning (ERP) system, scanning documentation, Device History Record (DHR) reviews)
• Leads CAPAs and audit finding corrections related to the QMS

EDUCATION QUALIFICATIONS

• High School Or Equivalent (Required)

EXPERIENCE QUALIFICATIONS

• 2+ Years of Experience in Quality (Required)
• 3+ Years of experience with quality systems in a highly regulated industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)
• Experience utilizing basic blueprints (Preferred)
• Experience using Microsoft Excel, Word, and Powerpoint (Required)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Accuracy and Attention to Detail - Working Experience
• Data Analysis Tools - Working Experience
• ISO 9001 (Quality Management) - Basic Knowledge
• Organization - Basic Knowledge
• Computer Knowledge - Working Experience
• ISO 13485 - Basic Knowledge

PHYSICAL DEMANDS

• Must be able to remain in a stationary position - Frequently
• Must be able to move about the inside of the building - Occasionally
• Must be able to communicate and exchange information with others - Constantly
• Must be able to distinguish and detect information such as writing and defects - Constantly

PAY RATE

For positions located in California, pay for this job type falls within the following range and varies based on scope and complexity of job responsibilities.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

WHAT WE OFFER

• Opportunity to work in a growing company
• Ability to help people live a longer, more active life
• Comprehensive benefit package
• Ability to work in an organization that values:
  • Integrity First: We do the right thing
  • Teamwork: We are one Orchid
  • Results: Our results matter

ADDITIONAL REQUIREMENTS

• Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
• Candidates must be able to provide proof of eligibility to work in the United States through eVerify

At Orchid, we fully support a diverse and inclusive workplace and we are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability.

Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through our preferred vendor job board by recruiters, employment agencies, or other parties.