The objective for this position is to provide Human Resource and Quality support to the facility and the staff. This employee will be responsible for completing routine, as well as complex tasks.
- High school diploma or general education degree (GED);
- One to three years related experience and/or training;
- Combination of education and experience will be considered in lieu of requirement
- Has a working knowledge of Microsoft Word, Excel, PowerPoint, and Outlook. Excel skills should be at an intermediate level.
- Strong attention to detail.
- Great written and verbal skills.
- Previous experience with ISO 9001 and/or ISO 13485 regulations.
- Previous experience with FDA 21 CFR 820 regulations.
- Will be trained on SAP computer program.
- Will be trained in ADP time keeping system.
Minimal, however must display willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
JOB TASKS & DUTIES
PHYSICAL ACTIVITY REQUIRED FOR THIS POSITION
- Quality Assurance Coordinator
- Lead a culture of Quality within the facility, including Expectations, Awareness, and Discipline;
- Update and maintain quality manual and documentation to ensure compliance to FDA 21 CFR 820 and ISO 13485:2016 regulations and standards.
- Review, revise, and create Standard Operating Procedures, Work Instructions, Forms, and training documents.
- Prepare and maintain quality trends.
- Perform internal audits to ensure compliance to required standards.
- Coordinate all quality claims from start to finish, not limited to, but including:
- Correspond with the customer and/or end user to resolve claims;
- Perform and/or delegate quality investigations on returned product;
- Determine containment actions, root cause, corrective, and preventive actions;
- Prepare, maintain, and present Corrective Action Reports.
- Update and maintain the Quality Claims log.
- Human Resource Assistant
- Perform new employee interviews and orientations, including all aspects of onboarding including E-Verify, Drug, and Background screening.
- Post job openings and assist with recruitment efforts.
- Coordinate facility events.
- Communicate announcements, medical benefits, 401K, FMLA, and related information to all members of staff.
- Create, organize, and present PowerPoint presentations not limited to, but including:
- Employee training
- Management reviews
- Staff meetings
- Correspond with Staffing Agencies regarding staffing needs and permanent placements.
- Maintain employee personnel files.
- Assist with Plant Office duties when needed.
- Assist the Management team with reports, documents, and trends.
The position works primarily in the office, however trips throughout the manufacturing facility are frequent. While there are no significant physical demands required, the employee will be regularly required to sit and use their hands, speak clearly and listen,
and reach. Specific vision abilities required by this job include close vision.
Inside environmental conditions protected from weather conditions not exposed to any adverse environmental conditions.
We are an EEO/AA Employer. We do not discriminate in hiring on the basis of race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at firstname.lastname@example.org and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis.
Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.For more information, about our commitment to equal employment opportunity, view the EEO is the Law Poster and Pay Transparency Statement.