Senior Quality Coordinator
Orchid Orthopedic Solutions
Okemos, MI
ABOUT US
Orchid Orthopedic Solutions provides solutions for orthopedic implant procedures enabling a longer, active life. Working in an industry that has the ability to impact lives in such a profound way has proved to be a strong motivator for Orchid. The Lansing facility specializes in the forging and machining of hip and knee implants across our 3 campus. A career with Orchid provides growth opportunities, a great benefits package including performance bonuses, insurance, 401(k) with company match and paid time off. For more information, please visit www.orchid-ortho.com
SHIFT
LAN - Shift 1 ($0) (United States of America - Michigan)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.
WHAT YOU WILL DO
- 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
- Supports the complaint handling unit with containment, quality alert generation and training, and investigation
- Applies methodical problem solving methods to assist with scrap and rework reduction or other continuous improvement activities
- Support implementation and maintenance of QMS-related software
- Collects and analyzes product and process data
- Identifies opportunities and implements solutions for QMS and business process improvements
- Back up the Quality Documentation Coordinator on regulatory release activities pre per FDA QMSR and ISO 13485 when required
- Support quality and compliance by adhering to all procedures, work instructions, and forms per 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)
LICENSES AND CERTIFICATIONS
- ASQ, CQT, CQA, CQIA, or CQE (Preferred)
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
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
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
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
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.