PURPOSE: Assure compliance to ACC policies and procedures and applicable external standards. Provide recommendations to teams as they work within the different Quality System Elements, such as Design Control and investigation activities within all Quality Systems. Participate in all quality system investigations as needed, and other duties as assigned.
GENERAL RESPONSIBILITIES:
- Review and approve Material Specifications and Item Masters.
- Lead/participate in Quality Event investigations, and maintain Quality Event system.
- Lead investigation, corrective/preventive action and implementation of Quality Management System process improvements.
- Responsible for investigating and coordinating other quality system assignments (Complaints, CAPA’s, Deviations, audit findings etc.) in a timely manner.
- Participate in Quality Improvement Teams, Design Control Teams, and Risk Management Teams as a representative of the Quality Department;
- Write, revise, and train on standard operating procedures for continuous improvement;
- Perform Quality Assurance review of quality records, reports and data;
- Perform Internal Quality System Audits as assigned;
- Perform Supplier Quality System Audits as assigned;
- Participate in FDA, ISO, Internal, Customer, audits as required;
- Perform customer, distributor, and internal requests for quality information (i.e. paper audits, general information);
- Perform effectivity/follow up to ensure that CAPA’s and other QMS changes/updates are effective;
- Other duties as assigned, which may include, but are not limited to:
- Department trending for reporting;
- Assist in supporting the Annual Product Review program to meet company deadlines;
- Coordinate Management Review activities including preparation of Quality Department metrics and organization of metrics from all other areas;
- Perform training on Quality topics as needed;
- Ensure non-conforming material is handled when found, per the Management of Quality Events procedure.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Working knowledge of cGMP, ISO 13485, and other international standards
- High attention to detail and excellent organizational skills.
- Able to work in a fast paced team environment.
- High degree of critical thinking skills
- Excellent oral and written communication skills.
- Excellent use of Microsoft Excel (graphing techniques), Word (formatting, spelling, creating tables), PowerPoint.
- Ability to work with others and teams to resolve quality issues and ability to work independently without supervision.
EDUCATION AND EXPERIENCE:
- A minimum of a Bachelor’s degree or equivalent combination of experience and/or education required.
- Must have previous QA/QC experience in a regulated environment.
GENERAL COMPETENCIES:
- Adapts to change, open to new ideas and responsibilities.
- Communicates well (written and verbal), delivers presentations, has good listening skills.
- Performs tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held.
- Good listener, committed to finding solutions to problems, works well with difficult people.
- Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers.
- Able to reach fact based decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions.
- Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record.
- Honest, accountable, maintains confidentiality.
- Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback.
- Information organized and accessible, maintains efficient work space, manages time well.
- Strives to understand contributing factors, works to resolve complex situations.
- Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices.
- Manages workload, works efficiently, and meets goals and objectives.
- Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; compliant with quality system requirements.
- Meets deadlines, establishes appropriate priority, and gets the job done in a timely manner.
- Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity.
PHYSICAL REQUIREMENTS:
Constantly sit, occasionally stand, and frequently walk. Occasionally use hands to finger, handle or feel. Occasionally reach with hands or arms, occasionally climb or balance, stoop, kneel, crouch or crawl. Constantly talk. Lift 11 to 25 lbs., 1-33% of the time. Carry 11 to 25 lbs., 1-33% of the time. Occasionally exposed to toxic or caustic chemicals.
SALARY:
$60,000-$84,000 a year
PAY RANGE DETAILS
The pay range listed on each job posting at acc represents the anticipated compensation range for new hires. Actual compensation will be determined based on several factors, including the candidate’s work history, experience, skills, and education. This range does not include the value of the total benefits package (if applicable), which includes, among other benefits, healthcare, dental, vision, and retirement benefits. Annual salaries are based on full-time employment.
BENEFITS:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Referral program
- Tuition reimbursement
- Vision insurance
